Label: information for the user

Pepcid10 mgcoated tablets

Famotidine

Read this label carefullybefore starting to take this medication,because it contains important information for you.

Follow exactly the medication administration instructions contained in this label or those indicated by your doctor or pharmacist.

-Keep this label, as you may need to refer to it again.

-If you need advice or more information, consult your pharmacist

-Ifyou experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this label.

-You should consult a doctor if you worsen or do not improveafter7 days of treatment.

Famotidine belongs to a group of medications that act on stomach acid-producing cells, reducing their production.

Pepcid is indicated for the reliefand treatmentofsymptomatic stomach acid and heartburn in adults and children over 16 years old.

You should consult a doctor if it worsens or does not improve after 7 days of treatment.

Do not take Pepcid

- If you are allergic to famotidine or any of the other components of this medication (listed in section 6).

- If you are allergic to other H2 antagonists (antihistamines) as cross-reactivity has been observed.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pepcid:

- If you experience unexplained weight loss.

- If you are middle-aged or older and experience stomach discomfort for the first time or if your symptoms have recently changed.

- If you have liver or kidney problems.

- If you experience difficulty swallowing or if stomach discomfort persists.

- If you have a history of allergy to other medications in this group (cimetidine, nizatidine, ranitidine).

Discontinue treatment and consult your doctor if you experience difficulty or pain swallowing, severe vomiting, black stools, choking, or chest pain.

Treatment should not exceed 7 days, if there is no improvement or worsening, consult your doctor.

To avoid stomach discomfort related to hyperacidity (heavy digestion, burning, and acidity), avoid smoking, eat regular meals, do not consume alcohol, and avoid stressful situations.

If you are to undergo any diagnostic tests (including blood tests, skin tests using allergens, etc.) inform your doctor that you are taking this medication, as it may alter the test results.

Children and adolescents

Children under 16 years should not take this medication.

Taking Pepcid with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication:

• Calcium carbonate, when used to treat elevated phosphate levels in blood (hyperphosphatemia) in patients on dialysis.
• Do not take antacids (bicarbonates, carbonates, hydroxides, aluminum, magnesium, calcium, etc.) until 2 hours after taking this medication.

• If you are taking oral preparations containing ketoconazole or itraconazole (antifungals), avoid taking medications that reduce stomach acidity (e.g. famotidine 10 mg) and should take famotidina always 2 hours after the antifungal.

• This medication may reduce the effects of preparations containing iron salts.

• Pepcid may reduce the effect of posaconazole oral suspension (medication used to drink to prevent and treat some fungal infections).
• Pepcid may reduce the effect of dasatinib, erlotinib, gefitinib, or pazopanib (medications used to treat cancer).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Women who are breastfeeding should discontinue treatment with famotidine or interrupt breastfeeding.

Driving and operating machinery

Although no effects are expected, if you experience dizziness, do not drive or operate hazardous machinery.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Adults and adolescents over 16 years:

The recommended dose is 1 tablet when symptoms appear, or 1 tablet 1 hour before eating to prevent symptoms associated with food and drink.

Do not take more than 2 tablets daily.

The treatment duration should not exceed 1 week.

This medication is taken orally.

Swallow the tablets whole with the help of a liquid.

Use in children and adolescents

Children under 16 years should not take this medication.

Use in elderly patients

Elderly patients experiencing stomach discomfort for the first time or unexplained weight loss should consult their doctor before taking this medication.

Use in patients with renal insufficiency

Consult a doctor before using this medication. A dose adjustment may be necessary.

If you take more Pepcid than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91 562.04.20 (indicating the medication and the amount ingested).

If you forgot to take Pepcid

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The most frequent adverse effects are headache and dizziness.

Other adverse effects are:

Rare (may affect up to 1 in 100 people):

- excessive intestinal gas

Rare (may affect up to 1 in 1,000 people):

- constipation and diarrhea

Very rare (may affect up to 1 in 10,000 people):

- hypersensitivity, anaphylaxis, angioedema

- reversible psychiatric disorders such as depression, anxiety, agitation, confusion, and hallucinations

- dizziness, asthenia, fatigue, and somnolence

- nausea and/or vomiting, abdominal discomfort, pain or distension, loss of appetite, dry mouth

- cholestatic jaundice, liver enzyme alterations

- toxic epidermal necrolysis, skin rash, pruritus, urticaria

- joint pain (arthritis), muscle cramps

- discomfort

- hair loss

Reporting Adverse Effects

If you experience any type of adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Store below 30°C. Keep the container perfectly closed to protect it from moisture.

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

Do not use this medication after the expiration date that appears on the container after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the Pharmacy Take-Back Point. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Pepcid Composition

-The active ingredient is Famotidine 10 mg per coated tablet.

-The other components are: hydroxypropyl cellulose, magnesium stearate, hypromellose, microcrystalline cellulose, pregelatinized cornstarch, iron oxide red (E172), talc, titanium dioxide (E171), and carnauba wax.

Appearance of the product and contents of the packaging

They are pale pink coated tablets.

Pepcid is presented in packaging of 6 and 12 coated tablets.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

JNTL Consumer Health (Spain), S.L.

C/ Vía de los Poblados 1, Edificio E, planta 3

28033-Madrid

Spain

Responsible Manufacturer:

JANSSEN-CILAG, S.P.A.

Vía C.Janssen

04010 Borgo S.Michele, Latina (Italy)

Last review date of this leaflet: September 2018

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http: //www.aemps.gob.es/.