Guideline

• Subheadings where there is a lack of relevant information may be excluded. However, the subheadings “Graviditet och amning” [Pregnancy and breast-feeding] and “Körförmåga och användning av maskiner” [Driving and using machines] are to be included and contain information in accordance with the SmPC.

Guideline

• Use of uppercase letters in the full name (and other text in the package leaflet) should be avoided for better legibility. If the product name has been approved with uppercase letters, the product name can be written in uppercase letters in the heading of the package leaflet, but in lowercase letters in the rest of the text.
• If the short term for the pharmaceutical form is used on the labelling (e.g. “tablett” [tablet] instead of “filmdragerad tablett” [film-coated tablet]), it is also stated in the package leaflet in Section 6 (and in the SmPC Section 3). For accepted short terms, see EDQM Standard Terms (ref. 3).
• State the name of the active substance(s), including the first letter, in lowercase letters.
• State the active substance(s) so that it reflects the strength stated directly after the name of the medicinal product. Note that even though the active substance(s) is/are stated in connection with the name of the medicinal product, it/they shall also always be specified in the declaration (see Section 13:6 d).
  • Example 1. If the medicinal product has a strength of 8 mg and contains buprenorphine hydrochloride 8.64 mg equivalent to buprenorphine 8 mg, then buprenorphine shall be stated in connection to the name of the medicinal product.
  • Example 2. If the medicinal product has a strength of 20 mg and contains 20 mg omeprazole hydrochloride equivalent to 19.52 mg omeprazole, then omeprazole hydrochloride shall be stated in connection to the name of the medicinal product.

Guideline

• Also state the medicinal product’s positive effect(s) in an objective and balanced way.
  • Example 1. X reduces HIV-1 in your body and this strengthens your immune system (your body’s natural defence) and reduces the risk of developing illnesses associated with a HIV infection.
  • Example 2. Repeated blood transfusions can lead to a build-up of excess iron. The reason is that blood contains iron and your body has no natural way of excreting the excess iron that you receive through your blood transfusions. Over time, the excess iron can damage vital organs, such as the liver and heart. Medicinal products referred to as iron chelators are used to remove excess iron and reduce the risk of organ damage.
  • Example 3. X belongs to a group of medicinal products called antidepressants, and you have been prescribed this product to treat your depression. X reduces depressive symptoms, including dejection, inner tension (anxiety), sleep disruptions (less sleep), reduced appetite, concentration difficulties, feelings of worthlessness, loss of interest in favourite activities and a sense of being slow.
  • Example 4. X dilates the blood vessels and thereby reduces the strain on the heart and the heart’s need of oxygen.

Guideline

• The symbol ▼ and a standardised explanation are included in the QRD template.

• Medicinal products having both packaging that may be sold without a prescription and packaging that is prescription only, should have separate package leaflets. Indication can be narrower for a non-prescription medicinal product. Non-prescription medicinal products should have separate package leaflets for different strengths to avoid the risk of incorrect doses.
• Use the following text if there is an approved medicinal product containing the same active substance(s) (Blue Box) (ref. 2):
  <{Active substance(s)} som finns i {product name} kan också vara godkänd för att behandla andra <sjukdomar> <tillstånd> som inte nämns i denna produktinformation. Fråga läkare, apoteks- eller annan hälso- och sjukvårdspersonal om du har ytterligare frågor och följ alltid deras instruktion.> [{Active substance(s)} in {product name} may also be approved for use in the treatment of other illnesses/conditions not mentioned in this product information. Ask your doctor, pharmacist or other health care professionals if you have any questions and always follow their instructions.]
• The Blue Box concept for package leaflets is not applicable to centralised procedures.
• Therapeutic indications for herbal medicinal products are stated as follows:
  <{Växtbaserat läkemedel använt {indication}.> [Herbal medicinal product used {indication}.]
  Therapeutic indications for traditional herbal medicinal products are stated as follows:
  <{Traditionellt växtbaserat läkemedel använt {indication}.

Indikationerna för ett traditionellt växtbaserat läkemedel grundar sig uteslutande på erfarenhet av långvarig användning.> [Traditional herbal medicinal product used {indication}. The product is a traditional herbal medicinal product for use in <the specified indication> <specified indications> exclusively based upon long-standing use.] (See also Section 12 a)

• State all of the contraindications.
• Explain why the medicinal product should not be taken in certain circumstances, e.g. “Kan öka risken för hjärtsvikt” [May increase the risk of heart failure].

• Clarify how these precautions are taken, e.g. “Ta inte fler tabletter än rekommenderad dos” [Do not take more tablets than the recommended dose]. Explain why, e.g. “Du får inte bättre smärtlindring men risken för biverkningar ökar” [You will not get better pain relief, but the risk of side effects increases].

• Use of the following wording is suggested. “X kan påverka eller påverkas av vissa läkemedel som innehåller följande aktiva substanser:” [X may affect or be affected by certain medicinal products that contain the following active substances:]. This sentence is then followed by a bulleted list of the different substances. State the therapeutic uses to help explain what the substances are, e.g. “erytromycin (används mot infektioner)” [erythromycin (used to treat infections)], and/or the type of medicinal product, e.g. “erytromycin (antibiotikum)” [erythromycin (antibiotic)]. It makes no difference whether the explanation or substance is in parentheses, but be consistent.
  If there is a large quantity of medicinal products with which concomitant use is contraindicated, a reference to the section about contraindications may be more suitable than repeating the information as in the example above.
• If it helps the user, there should be an explanation of why the product should not be combined with other medicinal products, e.g. “Kan öka risken för biverkningar” [May increase the risk of side effects], “Effekten av X kan öka/minska om…” [The effect of X may increase/decrease if…], “Effekten av {the other medicinal product} kan öka/minska om…” [The effect of {the other medicinal product} may increase/decrease if…].
• If there is cause to do so, also state the length of time to allow between taking different medicinal products.
• Interactions with substances that are not registered in Sweden may still be listed. These may be unauthorised medicinal products commonly used under special permission or come into question when medicinal products are obtained abroad.
• The previously used term naturläkemedel [natural ies] should be replaced with:
  • In general term, “naturläkemedel” [natural medicinal products] is replaced with “(traditionella) växtbaserade läkemedel och naturläkemedel” [(traditional) herbal medicinal products and natural ], e.g. “Tala om för läkare eller apotekspersonal om du tar eller nyligen har tagit andra läkemedel, inklusive (traditionella) växtbaserade läkemedel och naturläkemedel” [Tell your doctor or pharmacist if you are taking or have recently taken other medicinal products, including (traditional) herbal medicinal products and natural medicinal products].
  • In specific cases, e.g. that of St. John's wort, “naturläkemedel som innehåller johannesört” [natural medicinal products containing St. John's wort] is replaced with “(traditionella) växtbaserade läkemedel som innehåller johannesört” [(traditional) herbal medicinal products containing St. John's wort].

• Explain why medication should not be combined with certain foods/drinks, e.g. grapefruit juice, other acidic fruit juice, milk. If there is cause to do so, also state the length of time to allow between the food/drink and the medicinal product they interact with.
• Where appropriate, provide information about combining the medicinal product with alcohol. Explain why this combination is inappropriate (increased risk of side effects, interaction, inappropriate in conjunction with certain diseases, etc.)

The following are a few examples of standard texts to be used for certain substances or groups of medicinal products. Note that this is not an exhaustive list of warnings:

Acetylsalicylic acid:

<Läkemedel som innehåller acetylsalicylsyra ska inte ges till personer under 18 år med feber utan att läkare tillfrågats beroende på risken för uppkomst av Reyes syndrom, ett sällsynt men allvarligt sjukdomstillstånd.> [Medicinal products containing acetylsalicylic acid is not to be given to individuals below 18 years of age with fever without consulting a doctor due to the risk of developing Reye’s syndrome, a rare but severe condition.]

Cytostatics:

 <Om går sönder eller löses upp, tvätta händerna omsorgsfullt med vatten.> [If the <tablet><capsule> breaks apart or is dissolved, wash hands carefully with water.]

NSAID:

<Ska inte användas om du har eller har haft magsår eller om du är överkänslig mot acetylsalicylsyra. Har du astma bör du rådfråga läkare innan du använder X.> [Do not use if you have or have had stomach ulcers or you are sensitive to acetylsalicylic acid. You should consult a doctor before using X if you have asthma.]

Paracetamol:

<Använd inte X utan läkares ordination om du har alkoholproblem eller leverskada och använd inte heller X tillsammans med alkohol. Berusningseffekten av alkohol ökar inte genom tillägg av X. Om du använder andra smärtstillande läkemedel som innehåller paracetamol ska du inte använda X utan att först tala med läkare eller apotekspersonal. Ta aldrig mer X än vad som står under doseringsanvisningarna. Högre doser än de rekommenderade ger inte bättre smärtlindring utan medför istället risk för mycket allvarlig leverskada. Symtomen på leverskada kommer normalt först efter ett par dagar. Därför är det viktigt att du kontaktar läkare omedelbart om du har tagit för stor dos, även om du mår bra.> [Do not use X without doctor’s prescription if you have alcohol problems or liver damage and also do not use X with alcohol. The intoxicating effect of alcohol does not increase through the use of X. If you use other analgesics containing paracetamol you must not use X without first consulting a doctor or pharmacist. Never take more X than what is stated in the dosing instructions. Higher doses than recommended will not lead to better pain relief, instead it increases the risk of very severe liver damage. The symptoms of liver damage usually appear after a few days. It is therefore important that you contact a doctor immediately if you have taken too high a dose, even if you are feeling fine.]

<Förvaras utom syn- och räckhåll för barn och ungdomar.> [Keep this medicine out of the sight and reach of children and adolescents.]

The last sentence replaces the standard wording <Förvaras utom syn- och räckhåll för barn> [Keep this medicine out of the sight and reach of children.].

Benzoyl peroxide products and tretinoin:

 <Undvik solning, även i solarier vid behandling med detta läkemedel.> [Avoid sunbathing, including using sunbeds, in connection with treatment with this medicinal product.]

Steroids for topical use:

 <Undvik att få <läkemedlet> <salvan> <X> i ögonen.> [Avoid getting <the medicinal product><ointment><X> in your eyes.]

Guideline

• All information according to SmPC shall be reflected here. It is not enough to refer to a doctor. If a contraceptive is recommended, it must also say that the patient should discuss the choice of contraceptive with the doctor.
• It must be clearly stated whether you can or cannot use the medicinal product during pregnancy or breastfeeding.
• The standard phrase on pregnancy shall only be used when relevant. Examples where the phrase should not be used:
  • Medicinal products intended for children only.
  • Medicinal products that must never be used during pregnancy and breastfeeding.
  • Medicinal products that can be used during pregnancy and breastfeeding without restrictions.
• If the medicinal product may have an effect on fertility, this must be indicated (e.g. cytostatic). If no such effect exists/has been studied, nothing is indicated.
• In cases where the medicinal product may affect fertility and male/female reproduction, replace these terms with, e.g., “möjlighet att få barn” [the ability of having children].
• The section “Pregnancy, breastfeeding and fertility” can be perceived as irrelevant for men or for women who are not planning a pregnancy. It may be necessary to add subheadings such as
  •  <Preventivmedel för <män> <och> <kvinnor>> [Contraceptives for <men> <and> <women>]
  • <Fertilitet för <män> <och> <kvinnor>> [Fertility in <men> <and> <women>]
  • <Män:> [Men:]
  • <Kvinnor:> [Women:]
  • <Om du planerar att skaffa barn> [If you are planning on having children]
• Information regarding contraceptives (such as need for multiple forms of protection, including at least one barrier method) should be indicated, for example in the section on special warnings.

Guideline

• The following types of sentence may be used:
  <Kör inte bil eller annat fordon därför att…> [Do not drive a car or other vehicle due to…]
  <Använd inte verktyg eller maskiner därför att…> [Do not operate tools or machines due to…]
• Include any adverse reactions from the SmPC that may affect the ability to drive a vehicle or use machinery. Examples of such adverse reactions are tiredness, dizziness or impaired vision. Please note that even if studies show that the medicinal product has a small or no effect on the ability to drive, it may be of value to include supplementary information about disease symptoms and adverse reactions in both the SmPC and the package leaflet.
• Include the following text for the majority of medicinal products (Blue Box).
  <Du är själv ansvarig för att bedöma om du är i kondition att framföra motorfordon eller utföra arbeten som kräver skärpt uppmärksamhet. En av faktorerna som kan påverka din förmåga i dessa avseenden är användning av läkemedel på grund av deras effekter och/eller biverkningar. Beskrivning av dessa effekter och biverkningar finns i andra avsnitt. Läs därför all information i denna bipacksedel för vägledning. Diskutera med läkare eller apotekspersonal om du är osäker.> [You are responsible for judging whether you are fit to drive motorised vehicles or carry out work that needs focused attention. One of the factors that can affect your abilities in these respects is the use of medicines due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Therefore, read all the information in this package leaflet for guidance. Discuss the matter with a doctor or pharmacist if you are unsure.]
• Exceptions from the introduction of the Blue Box wording may be made for those medicinal products that contain information in the corresponding section of the SmPC that the medicinal product has no effect or a negligible effect on the ability to drive vehicles and use machinery. Exceptions may also be made for certain types of medicinal product for which the Blue Box is deemed to be irrelevant, e.g. vitamin preparations, emollients and ointments.
• Please note that the Blue Box wording shall be included in the package leaflet if the SmPC and package leaflet list adverse reactions that may affect the ability to drive vehicles etc., even if the SmPC indicates that the medicinal product has no effect or a negligible effect on the capacity to drive a vehicle or use machinery.
• The Blue Box concept for package leaflets is not applicable to centralised procedures. However, the information as such can be used.

Guideline

Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ and its translations is available on the EMA website. There is also a document with background information and FAQs.

Guideline

1. State how the patient/healthcare professionals shall dose and administer the medicinal product. In the case of long or complicated dosage instructions, the following may be written, e.g.: “Läkaren kommer att avgöra vilken dos som är lämplig för dig” [Your doctor will decide which dose is appropriate for you].
   Information about how the medicinal product is to be taken (e.g. with or without food/drink) is provided.  If there is reason to do so, also give a time interval in relation to food/drink (also see Section 17:4 c)
2. State the route of administration in a way that is easy for patients to understand. The following types of sentence may be used:
   • <Svälj <läkemedelsformen> <X> med ett glas <vätska> <vatten>.> [Swallow <pharmaceutical form> <X> with a glass of <liquid><water>.]
   • Where appropriate, this is combined with <Får inte tuggas eller krossas.> [May not be chewed or crushed.], followed by an explanation.
   • Include relevant instructions, e.g. <tuggas> [to be chewed], <omskakas> [shake before use], <ska spädas> [to be diluted], <löses i ett glas <vätska> <vatten>> [dissolve in a glass of <liquid><water>]. Specify appropriate liquids in cases where water is not stated.
   • Possibly supplement this information with images. Detailed instructions for use may be placed at the end of the package leaflet. This should be referenced in the administration section. The package leaflet and instructions for use must be attached as a cohesive unit. They may not be separated into two parts (sheet/leaflet) in the packaging. If the packaging has multiple languages, one language can be indicated per unit.
     The user instruction can be a “tear off”.
   • Describe non-patient-friendly methods of administration with a more patient-friendly translation. For example according to the table below:

For more complicated pharmaceutical forms, complement this section with a description of the pharmaceutical form that includes clarifying information, e.g.

• Modified-release tablets: Tabletterna är utformade så att det verksamma ämnet finns i två lager. Från det ena lagret frisätts det verksamma ämnet snabbt och från det andra sker frisättningen stegvis under lång tid. På så sätt har läkemedlet både en snabb och långvarig verkan. [The tablets are formulated so that the active ingredient is in two layers. The active ingredient is released quickly from one layer and gradually, over a long period, from the other. This allows the product to have an effect that is both quick and long lasting].
• Oral suspension/solution: it is important to state that this liquid is to be swallowed.
• Orodispersible tablet: Löser upp sig i munnen [Dissolves in the mouth].

Other information that is valuable to the user, e.g. <munnen bör sköljas efter varje inhalation> [rinse mouth after inhalation], <kan färga hud, hår och kläder> [may cause discolouring of skin, hair and clothes], <kan färga urinen/avföringen> [may colour urine/faeces], <kan missfärga mjuka kontaktlinser> [may discolour soft contact lenses], may be provided.

Instructions for use directed at healthcare professionals is placed at the end of the package leaflet. The information should primarily cover preparation instructions, storage conditions (including following preparation), shelf life, any protective stipulations for the healthcare professionals and, e.g., warnings about reactions that may occur during administration.

c) -

Guideline

d) If possible, state how long the course of treatment should continue (short course/long term treatment). Include a recommendation to contact a doctor if the expected effect is not achieved, if relevant. Specify what the expected effect involves, or which symptoms the patient is to be observant of.

e) Include the following phrase in the section with the following sentence (Blue Box):
“Om du fått i dig för stor mängd läkemedel eller om t.ex. ett barn fått i sig läkemedlet av misstag kontakta omedelbart läkare, sjukhus eller Giftinformationscentralen (tel. 112) för bedömning av risken samt rådgivning.” [If you have taken a too large dose of the medicinal product, or if a child mistakenly taken the product, contact a doctor, hospital or poison information centre (tel: 112) immediately for risk assessment and advice.]
For hospital products, this Blue Box text will often need to be reformulated or excluded. In case of translations from English, it may be necessary to reformulate/adapt the text in this section in order to avoid repetition in the Swedish text.
The Blue Box concept for package leaflets is not applicable to centralised procedures.

f) Provide examples of what to do when one prescribed dose has been missed, e.g. in conjunction with a meal or bedtime.
Also state the period of time that applies to different measures, e.g. after how long the dose shall be skipped completely.

g) List the symptoms that can arise when the medicinal product is withdrawn. Also provide information about medicinal products that require gradual reduction. Reference to the section on adverse reactions can be made.

h) -

Guideline

• All adverse reactions that are listed in the SmPC shall be included in the package leaflet.

First part of this section – serious adverse reactions:

• The section starts with the following: <Sluta ta X och> kontakta <omedelbart> <snarast> läkare eller uppsök närmaste akutmottagning om du upplever följande symtom: [<Stop taking X and> <immediately> <promptly> contact a doctor or go to the emergency centre if you experience the following symptoms:]
• Consider the adverse effects listed for similar medicinal products.
• The frequency should be indicated for the patient to know how often/rarely they occur, so that the message is not unnecessarily disconcerting.
• The following texts should be used if any of the following conditions are named as a warning or side effect in the SmPC:
  
  Agranulocytosis:
  <Sluta ta X och kontakta omedelbart läkare om du får något av följande symtom (agranulocytos): feber i kombination med kraftigt försämrat allmäntillstånd eller feber i kombination med ont i halsen/svalget/munnen eller svårt att kissa, vilket är tecken på infektion. Eftersom X i sällsynta fall kan leda till ett försämrat infektionsförsvar på grund av brist på vita blodkroppar kan infektioner bli allvarliga. Därför är det viktigt att du i dessa situationer också informerar om din medicinering.>
  [<Stop taking X and immediately contact a doctor if you experience one of the following symptoms (agranulocytosis): fever coupled with a severely deteriorated general state of health or a fever in combination with sore throat/mouth or difficulty urinating, which are signs of infection. As X can in rare cases lead to a deteriorated immune system due to a lack of white blood cells, infections can become serious. For this reason, it is also important that you inform health care personnel about your medication.>]
  
  Stevens-Johnson syndrome / TEN / DRESS / AGEP:
  <Sluta ta X och kontakta omedelbart läkare eller uppsök närmaste akutmottagning om du upplever följande symtom:
  Extremt kraftiga och allvarliga hudbiverkningar såsom <Stevens-Johnsons syndrom>, <toxisk epidermal nekrolys>, <läkemedelsreaktion med eosinofili och systemiska symtom (DRESS)>, <akut generaliserad exantematös pustulos (AGEP)> har rapporterats vid användning av X.
  
  Hudbiverkningarna kan bestå av utslag med eller utan blåsor. Även hudrodnad, <sår eller svullnad i mun, hals, ögon, näsa och runt könsorganen (Stevens-Johnsons syndrom)>, <ödem (DRESS)> samt feber och influensaliknande symtom kan förekomma.>
  
  [<Stop taking X and immediately contact a doctor or go to the emergency department if you experience the following symptoms:
  
  Extremely intense and serious skin reactions, such as <Stevens-Johnson syndrome>, <toxic epidermal necrolysis>, <drug rash with eosinophilia and systemic symptoms (DRESS syndrome)>, <acute generalised exanthematous pustulosis (AGEP)> have been reported during use of X.

  The adverse reaction of the skin may appear as rashes with or without blisters. Skin irritation, <sores or swelling in the mouth, throat, eyes, nose and around the genitals (Stevens-Johnson syndrome)>, <oedema (DRESS syndrome)> and fever and flulike symptoms may occur.>]

  If Stevens-Johnson syndrome / toxic epidermal necrolysis is/are included, add the following:

  <Hudutslagen kan utvecklas till allvarlig utbredd hudskada (hudavlossning av överhuden och ytliga slemhinnor) med livshotande följder.>

  [<The skin rashes may develop into serious widespread skin damage (peeling of the epidermis and superficial mucous membranes) with life-threatening consequences.>]

  If DRESS syndrome is included, add the following:

  <Symtom på DRESS utvecklas vanligen cirka 2-6 veckor (eventuellt upp till 8 veckor) efter behandlingsstart.>
  [<Symptoms of DRESS syndrome usually appear approximately 2–6 weeks (possibly up to 8 weeks) after treatment begins.>]

  If AGEP is included, add the following:

  <Om symtom på AGEP uppstår sker detta ofta i nära anslutning till behandlingsstart.>
  [<If symptoms of AGEP appear, it usually occurs in conjunction with the start of treatment.>]

  Angiooedema:

  <Sluta ta X och kontakta omedelbart läkare om du får något av följande symtom (angioödem):
  svullnad av ansikte, tunga eller svalg; svårigheter att svälja; nässelutslag och andningssvårigheter.>
  [Stop using X and immediately contact a doctor if you experience any of the following symptoms (angiooedema):
  swelling of the face, tongue or throat; difficulty swallowing; hives and breathing difficulties.]

  Rhabdomyolysis:

  <Sluta att ta X och kontakta läkare snarast möjligt om du får oförklarlig muskelsmärta, muskelkramper eller muskelsvaghet.>
  [Stop using X and contact a doctor as soon as possible if you experience inexplicable muscle pains, muscle cramps or muscle weakness.]

Second part of this section – other adverse reactions:

• Must be based on the list of other adverse reactions from 4.8 of SmPC. A heading should separate the paragraph from the previous one relating to serious adverse reactions, e.g. “Other side effects that may occur”.
• Adverse reactions may be grouped in cases where there are several different adverse reactions within the same organ system with similar symptoms. For example, various cardiac diagnoses can be described as <påverkan på hjärtats rytm> [effects on heart rate]. Information may be supplemented with <som visar sig vid <blodprov>, <EKG>, <provtagning> [that can be seen in <blood sample>, <ECG>, <medical sampling>].
• State the adverse reactions with terms that primarily describe symptoms. Use simple language. For certain groups of patients that can be expect to be better informed about their disease, a few more specific terms may be used. If medical terminology is used, this should be explained in Swedish terms or by using symptoms. If medical terminology is used, there should be a specific purpose, e.g. the term is recognised by the general public or the medical term describes the condition better or facilitates the search for further information. User tests have shown that medical terminology interrupts the reader's flow and makes it harder for the patient to absorb the information.
• Adverse reactions should be listed based on how frequently they occur, if this has been specified in the SmPC (avoid using %).

  The following description of frequency is recommended:

  Mycket vanliga (kan förekomma hos fler än 1 av 10 användare)

  [Very common: may affect more than 1 in 10 people]:

  Vanliga (kan förekomma hos upp till 1 av 10 användare)

  [Common: may affect up to 1 in 10 people]:

  Mindre vanliga (kan förekomma hos upp till 1 av 100 användare)

  [Uncommon: may affect up to 1 in 100 people]:

  Sällsynta (kan förekomma hos upp till 1 av 1000 användare)

  [Rare: may affect up to 1 in 1,000 people]:

  Mycket sällsynta (kan förekomma hos upp till 1 av 10 000 användare)

  [Very rare: may affect up to 1 in 10,000 people]:

  Har rapporterats (förekommer hos ett okänt antal användare)

  [Not known: frequency cannot be estimated from the available data]:

• The following text is recommended for reporting adverse reactions:

  Rapportering av biverkningar

  Om du får biverkningar, tala med <läkare> <,> . Detta gäller även biverkningar som inte nämns i denna information. Du kan också rapportera biverkningar direkt (se detaljer nedan). Genom att rapportera biverkningar kan du bidra till att öka informationen om läkemedels säkerhet.
  
  [Reporting of side effects
  If you get any side effects, talk to your <doctor> <or> <,> <pharmacist> <or nurse>. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see contact details below). By reporting side effects, you can help provide more information on the safety of this medicine.]

  Läkemedelsverket
  Box 26
  751 03 Uppsala
  www.lakemedelsverket.se

Guideline

• The following phrase is used to inform the user of the expiry date:
  Används före utgångsdatum som anges på <etiketten> <kartongen> <flaskan> <…> <efter {<Utg.dat.> eller <EXP> eller <Utg.dat. eller EXP>}.> <Utgångsdatumet är den sista dagen i angiven månad.>
  [Do not use this medicine after the expiry date which is stated on the <label> <carton> <bottle> <…> <after {abbreviation used for expiry date}.> <The expiry date is the last day of the month specified.>]
• If specific instructions apply to destruction of the product, one of the following may be used:
  
  Text for the pharmaceutical form patches
  <Använt plåster ska vikas ihop med den klibbiga sidan inåt och förvaras på ett säkert sätt så att barn inte kommer åt plåstret. Återlämna använt plåster till apotek, helst i originalförpackningen. > [Used patches shall be folded with the adhesive side inwards and stored in a safe way so that children cannot reach the patches. Return used patches to the pharmacy, preferably in the original package.]
  
  Medicinal products for asthma (inhalers) and similar.
  
  <Eftersom läkemedelsrester kan finnas kvar i de tomma förpackningarna bör man inte kasta dessa i soporna utan även de tomma förpackningarna bör återlämnas till apotek.> [Due to the possibility that pharmaceuticals may remain in the empty containers, these should not be disposed of in the household waste, the empty containers should be returned to the pharmacy.]

Guideline

• The declaration contains a list of the quantity of the form of the active substance(s) that correspond to the strength, e.g. buprenorphine hydrochloride equivalent to buprenorphine 8 mg.

Guideline

• Include a description of the pharmaceutical form and the medicinal product's appearance.
• In case of granules that have to be reconstituted to make an antibiotic suspension, <Bereds på apotek till oral suspension> [For preparation to oral suspension at pharmacy] can be written as the customer only sees the prepared suspension.
• All pack sizes shall be listed in accordance with the SmPC.
• For package leaflets for non-prescription medicinal products, only list the non-prescription pack sizes.
• For package leaflets for prescription-only medicinal products, list all pack sizes.

Guideline

• Use the heading <Innehavare av godkännande för försäljning> [Marketing authorisation holder]
• The subheading <Innehavare av godkännande för försäljning> [Marketing authorisation holder] is replaced by <Importör/information lämnas av:> [Importer/provider of information:] or <Importör:> [Importer:] for parallel imported medicinal products.
• The subheading <Innehavare av godkännande för försäljning> [<Marketing authorisation holder]> is replaced by <Innehavare av registrering för försäljning> [Registration holder] for traditional herbal medicinal products.
• The local representative is stated, if it is registered as such at the Swedish Medical Products Agency. Use the heading <Lokal företrädare> [Local representative].

If the stated company is not registered as a local representative at the Swedish Medical Products Agency, but only provides information about the medicinal product, the heading <Information lämnas av:> [Provider of information:] may be used instead.

• Complete address (preferably postal address) is stated in the package leaflet. In addition, telephone number, fax number and/or e-mail address may also be added. A reference to a web address is not acceptable.

Guideline

• The term manufacturer denotes the manufacturer responsible for releasing the batch (see the definition in Section 1 of HSLF‍-‍FS 2021:96).
• If the manufacturer is a company other than the MAH, the manufacturer is stated separately. Use the heading <Tillverkare> [Manufacturer]
• If the manufacturer is in the same group of companies as the MAH, the manufacturer does not need to be stated.  Use the heading <Innehavare av godkännande för försäljning och tillverkare> [Marketing authorisation holder and manufacturer]
• For parallel imported medicinal products, the re-packager and manufacturer's names and addresses shall be stated. A relevant company group term may be stated instead of the manufacturer's name and address, see Section 12 of HSLF-FS 2022:8. The information is preceded by <Ompackare> [Re-packager] and <Tillverkare> [Manufacturer].

Guideline

• The Swedish Medical Products Agency will add the date once the package leaflet is ready for approval.

Guideline

• Information in the package leaflet shall be consistent with the content of the SmPC and be otherwise beneficial for the user.
• The information should be concise.
• It is preferable to use the active form, e.g. “Ta tabletten med mat” [Take the tablets with food] instead of “Tabletterna tas med mat” [The tablets are taken with food].
• The medicinal product's positive properties should be presented in a balanced way, but may not contain advertising messages or emotive language.
• Particularly important information is given the appropriate prominence in each section. Prominent placement can be done with the help of bulleted lists, boxes or starting each section with particularly important information. Additional subheadings, aside from those already stipulated, may be used.
• For non-prescription medicinal products, the package leaflet and labelling shall contain sufficient information and be designed to allow the patient/customer to use the medicinal product without contacting a doctor.
• For non-prescription medicinal products, there are specific template texts in the QRD template and annotated QRD template (with instruction texts) for package leaflets.
• For non-prescription medicinal products, there are OTC substance reports for certain substances published on the Swedish Medical Products Agency's website. An OTC substance report is the result of an overview for a substance regarding non-prescription information (including pack sizes approved for non-prescription), which should be stated in the package leaflet/labelling for a medicinal product approved as non-prescription.
• A combined package leaflet may be used if the package leaflets are identical for more than one strength. In these cases, only the strength-specific information may differ. The aim of the combined package leaflet will be to clarify dosage instructions for the user, e.g. when a patient changes from one strength to another during their treatment.
  However, non-prescription medicinal products should have separate package leaflets for different strengths in order to avoid the risk of incorrect dosage.
• It is sufficient to provide one package leaflet in multipacks. Multipacks of parallel imported medicinal products should contain the same number of package leaflets as the directly imported medicinal product.
• The printed package leaflet shall be easily legible, even for those with impaired vision. The use of uppercase letters must be avoided. Good legibility may also be achieved by splitting the text up into short paragraphs with spaces between them. Use a clear and easily legible font. Avoid paper of a quality that allows text from one side to be visible on the other. Text divided up into a larger number of narrow columns is more easily legible than a small number of wide columns.
• Only information relating to the Swedish market may be stated in the Swedish package leaflet authorised by the Swedish Medical Products Agency.
• For traditional herbal medicinal products, it shall be stated that the user should consult a doctor if the symptoms persist during the use of the medicinal product or if adverse reactions not listed in the package leaflet occur.

Guideline

• Dose-dispensed medicinal products: the packaging does not need to contain package leaflets.
• Medicinal products that are not marketed in Sweden: prior to marketing, proposed package leaflets shall be sent to the Swedish Medical Products Agency for review and authorisation.
• For medicinal gases that are only made available in hospitals, and when the Swedish Medical Products Agency has accepted that the package leaflet will only be made available on the Swedish Medical Products Agency’s website, the following text appears on the labelling: “Läs produktinformation som finns tillgänglig på www.lakemedelsverket.se” [Read the product information published on the Swedish Medical Products Agency's website: www.lakemedelsverket.se]
  (What is stated above is valid when gas cylinders are stored in a gas storage facility and the gas is distributed via a pipe system to the treatment room).
• In addition to what is stated above, there are no general product categories that are granted exemptions, instead each individual case should be justified in the application.
• Please note that hospital products and radioactive medicinal products are, in general, not granted exemptions from the requirement to supply a package leaflet in the packaging. Patients who receive these medicinal products shall be able to obtain a package leaflet from healthcare professionals and be able to find this information retrospectively on the Swedish Medical Products Agency's website.