Gardasil - patient leaflet, side effects, dosage

1. What Gardasil is and what it is used for

Gardasil is a vaccine. Vaccination with Gardasil is intended to protect against diseases caused by Human Papillomavirus (HPV) types 6, 11, 16, and 18.

These diseases include pre-cancerous lesions of the female genitals (cervix, vulva, and vagina); pre-cancerous lesions of the anus and genital warts in males and females; cervical and anal cancers. HPV types 16 and 18 are responsible for approximately 70 % of cervical cancer cases, 75–80 % of anal cancer cases; 70 % of HPV-related pre-cancerous lesions of the vulva and vagina; 80 % of HPV related pre-cancerous lesions of the anus. HPV types 6 and 11 are responsible for approximately 90 % of genital wart cases.

Gardasil is intended to prevent these diseases. The vaccine is not used to treat HPV related diseases. Gardasil does not have any effect in individuals who already have a persistent infection or disease associated with any of the HPV types in the vaccine. However, in individuals who are already infected with one or more of the vaccine HPV types, Gardasil can still protect against diseases associated with the other HPV types in the vaccine.

Gardasil cannot cause the diseases it protects against.

Gardasil produces type-specific antibodies and has been shown in clinical trials to prevent HPV 6-, 11-, 16-, and 18-related diseases in women 16–45 years of age and in men 16–26 years of age. The vaccine also produces type-specific antibodies in 9– to 15-year-old children and adolescents.

Gardasil should be used in accordance with official guidelines.

2. What you need to know before you or your child receive Gardasil

Do not receive Gardasil if:

• you or your child is allergic (hypersensitive) to any of the active substances or any of the other ingredients of Gardasil (listed under “other ingredients”- see section 6).
• you or your child developed an allergic reaction after receiving a dose of Gardasil.
• you or your child suffer from an illness with high fever. However, a mild fever or upper

respiratory infection (for example cold) itself is not a reason to delay vaccination.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before vaccination if you or your child

• has a bleeding disorder (a disease that makes you bleed more than normal), for example haemophilia
• has a weakened immune system, for example due to a genetic defect, HIV infection or medicines that affect the immune system.

Fainting, sometimes accompanied by falling, can occur (mostly in adolescents) following any needle injection. Therefore, tell the doctor or nurse if you fainted with a previous injection.

As with any vaccine, Gardasil may not fully protect 100 % of those who get the vaccine.

Gardasil will not protect against every type of Human Papillomavirus. Therefore, appropriate precautions against sexually transmitted disease should continue to be used.

Gardasil will not protect against other diseases that are not caused by Human Papillomavirus.

Vaccination is not a substitute for routine cervical screening. You should continue to follow your doctor’s advice on cervical smear/Pap tests and preventative and protective measures.

What other important information should you or your child know about Gardasil

Longer term follow-up studies were conducted to determine the duration of protection. The need for a booster dose has not been established.

Other medicines or vaccines and Gardasil

Gardasil can be given with a Hepatitis B vaccine or with a combined booster vaccine containing diphtheria (d) and tetanus (T) with either pertussis [acellular, component] (ap) and/or poliomyelitis [inactivated] (IPV) (dTap, dT-IPV, dTap-IPV vaccines) at a separate injection site (another part of your body, e.g. the other arm or leg) during the same visit.

Gardasil may not have an optimal effect if:

• used with medicines that suppress the immune system.

In clinical trials, oral or other contraceptives (e.g. the pill) did not reduce the protection obtained by Gardasil.

Please tell your doctor or pharmacist if you or your child are taking or have taken recently any other medicines, including medicines obtained without a prescription.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Gardasil may be given to women who are breast-feeding or intend to breast-feed.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

Gardasil contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

• 3. How Gardasil is given

Gardasil is given as an injection by your doctor. Gardasil is intended for adolescents and adults from 9

years of age onwards.

If you are from 9 to and including 13 years of age

Gardasil can be administered according to a 2-dose schedule:

• – First injection: at chosen date

• – Second injection: 6 months after first injection

If the second vaccine dose is administered earlier than 6 months after the first dose, a third dose should always be administered.

Alternatively, Gardasil can be administered according to a 3-dose schedule:

• – First injection: at chosen date

• – Second injection: 2 months after first injection

• – Third injection: 6 months after first injection

The second dose should be administered at least one month after the first dose and the third dose should be administered at least 3 months after the second dose. All three doses should be given within a 1-year period. Please speak to your doctor for more information.

If you are from 14 years of age

Gardasil should be administered according to a 3-dose schedule:

• – First injection: at chosen date

• – Second injection: 2 months after first injection

• – Third injection: 6 months after first injection

The second dose should be administered at least one month after the first dose and the third dose should be administered at least 3 months after the second dose. All three doses should be given within a 1-year period. Please speak to your doctor for more information.

It is recommended that individuals who receive a first dose of Gardasil complete the vaccination course with Gardasil.

Gardasil will be given as an injection through the skin into the muscle (preferably the muscle of the upper arm or thigh).

The vaccine should not be mixed in the same syringe with any other vaccines and solutions.

If you forget one dose of Gardasil:

If you miss a scheduled injection, your doctor will decide when to give the missed dose.

It is important that you follow the instructions of your doctor or nurse regarding return visits for the follow-up doses. If you forget or are not able to go back to your doctor at the scheduled time, ask your doctor for advice. When Gardasil is given as your first dose, the completion of the vaccination course should be done with Gardasil, and not with another HPV vaccine.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all vaccines, this vaccine can cause side effects, although not everybody gets them.

The following side effects can be seen after the use of Gardasil:

Very common (may affect more than 1 in 10 patients), side effects found at the injection site include: pain, swelling and redness. Headache was also seen.

Common (may affect more than 1 in 100 patients), side effects found at the injection site include: bruising, itching, pain in extremity. Fever and nausea have also been reported.

Rare (may affect less than 1 in 1,000 patients): hives (urticaria).

Very rare (may affect less than 1 in 10,000 patients), difficulty breathing (bronchospasm) has been reported.

When Gardasil was given with a combined diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] booster vaccine during the same visit, there was more headache and injection-site swelling.

Side effects that have been reported during marketed use include:

Fainting, sometimes accompanied by shaking or stiffening, has been reported. Although fainting episodes are uncommon, patients should be observed for 15 minutes after they receive HPV vaccine.

Allergic reactions that may include difficulty breathing, wheezing (bronchospasm), hives and rash have been reported. Some of these reactions have been severe.

As with other vaccines, side effects that have been reported during general use include: swollen glands (neck, armpit, or groin); muscle weakness, abnormal sensations, tingling in the arms, legs and upper body, or confusion (Guillain-Barre Syndrome, Acute disseminated encephalomyelitis); dizziness, vomiting, joint pain, aching muscles, unusual tiredness or weakness, chills, generally feeling unwell, bleeding or bruising more easily than normal, and skin infection at the injection site.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Gardasil

Keep this vaccine out of the sight and reach of children.

Do not use this vaccine after the expiry date which is stated on the vial label and the outer carton (after EXP). The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C).

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Gardasil contains

The active substances are: highly purified non-infectious protein for each of the Human

Papillomavirus types (6, 11, 16, and 18).

1 dose (0.5 ml) contains approximately:

Human Papillomavirus Type 6 L1 protein2,3

Human Papillomavirus Type 11 L1 protein2,3

Human Papillomavirus Type 16 L1 protein2,3

Human Papillomavirus Type 18 L1 protein2,3

• 2L1 protein in the form of virus like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology.

• 3adsorbed on amorphous aluminium hydroxyphosphate sulfate adjuvant (0.225 milligram­s Al).

What Gardasil looks like and contents of the pack

1 dose of Gardasil suspension for injection contains 0.5 ml.

Prior to agitation, Gardasil may appear as a clear liquid with a white precipitate. After thorough agitation, it is a white, cloudy liquid.

Gardasil is available in packs of 1, 10 or 20 vials.

Not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

MSD VACCINS

162 avenue Jean Jaurès

69007 Lyon

France

Manufacturer

Merck Sharp & Dohme BV

Waarderweg 39

2031 BN Haarlem

The Netherlands

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgiqu­e/Belgien

MSD Belgium

Tél/Tel: +32 (0) 27766211

E^^rapus

MepK Oapn u ^oyM EMrapus EOO^, me^.: + 359 2 819 3737

Česká republika

Merck Sharp & Dohme s.r.o.

Tel.: +420 233 010 111

Danmark MSD Danmark ApS Tlf: + 45 4482 4000	Malta Merck Sharp & Dohme Cyprus Limited. Tel: 8007 4433 (+356 99917558)
Deutschland MSD Sharp & Dohme GmbH Tel: 0800 673 673 673 (+49 (0) 89 4561 0)	Nederland Merck Sharp & Dohme B.V. Tel: 0800 9999000 (+31 23 5153153)
Eesti Merck Sharp & Dohme OÜ Tel.: +372 6144 200	Norge MSD (Norge) AS Tlf: +47 32 20 73 00
EZZárta MSD A.O.B.E.E. TnX: +30 210 98 97 300	Österreich Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 044
España Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00	Polska MSD Polska Sp. z o.o. Tel.: +48.22.549.51.00
France MSD VACCINS Tél: +33 (0) 1 80 46 40 40	Portugal Merck Sharp & Dohme, Lda Tel: +351 21 4465700
Hrvatska Merck Sharp & Dohme d.o.o. Tel: +385 1 66 11 333	România Merck Sharp & Dohme Romania S.R.L Tel: + 4021 529 29 00
Ireland Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998700	Slovenija Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: +386.1.520.4201
Ísland Vistor hf. Sími: + 354 535 7000	Slovenská republika Merck Sharp & Dohme, s. r. o Tel: +421 2 58282010
Italia MSD Italia S.r.l. Tel: +39 06 361911	Suomi/Finland MSD Finland Oy Puh/Tel: +358 (0)9 804 650
Kùnpoç Merck Sharp & Dohme Cyprus Limited TnX: 800 00 673 (+357 22866700)	Sverige Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488

United Kingdom (Northern Ireland)

Merck Sharp & Dohme Ireland (Human Health)

Limited

Tel: +353 (0)1 2998700

This leaflet was last revised in: {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site:

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The following information is intended for medical or healthcare professionals only:

The vaccine should be used as supplied; no dilution or reconstitution is necessary. The full recommended dose of the vaccine should be used. Any unused product or waste material should be disposed of in accordance with local requirements.

Shake well before use. Thorough agitation immediately before administration is necessary to maintain suspension of the vaccine.

Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration. Discard the product if particulates are present or if it appears discoloured.

B. PACKAGE LEAFLET (PREFILLED SYRINGE)