ADALAT OROS 30 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Adalat Oros 30 mg, prolonged-release tablets

nifedipine

Contents of the pack

1. What Adalat Oros is and what it is used for
2. What you need to know before you take Adalat Oros
3. How to take Adalat Oros
4. Possible side effects
5. Storage of Adalat Oros
6. Contents of the pack and other information

1. What Adalat Oros is and what it is used for

The Adalat Oros tablet is an innovative prolonged-release system that acts as an osmotic pump that releases nifedipine through an orifice made in the tablet by laser technology. Once all the active substance has been released, the Adalat Oros tablet, which is indeformable, is excreted intact in the faeces.

The active substance, nifedipine, belongs to a series of medicines known as calcium antagonists. The drugs in this group dilate the coronary arteries, which increases blood flow and improves oxygen supply to the heart. On the other hand, nifedipine dilates the peripheral arterial vessels, which reduces high blood pressure.

Adalat Oros is indicated for the treatment of arterial hypertension, chronic stable angina pectoris (effort angina) and Raynaud's syndrome.

2. What you need to know before you take Adalat Oros

Do not take Adalat Oros:

• if you are allergic to nifedipine or any of the other ingredients of this medicine (listed in section 6).
• if you are being treated with rifampicin.
• if you have a colostomy bag.

Adalat Oros should not be administered if you are in cardiovascular shock.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine, especially:

• if you have hypotension (low blood pressure).
• if you have gastrointestinal narrowing.
• if you are regularly undergoing dialysis, have malignant hypertension and severe kidney disease or hypovolemia.
• if you have heart problems.
• if you have liver disease.
• in case of in vitro fertilization, as Adalat Oros 30 may reduce the chances of conception.

Additionally, inform your doctorbefore taking Adalat Oros if you have any of these conditions:

• if you are going to undergo a radiological examination, as the test results may be altered by treatment with this medicine.

Children and adolescents

Adalat Oros is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Adalat Oros

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Certain medicines may interact with Adalat Oros; in these cases, your doctor will need to adjust the dose or discontinue treatment with one of the medicines. This is especially important when taking:

• Other medicines to lower high blood pressure; such as diltiazem.
• Cardiotonics, such as digoxin.
• Antiepileptics, such as phenytoin, phenobarbital or carbamazepine; valproic acid.
• Antiarrhythmics, such as quinidine.
• Immunosuppressants, such as tacrolimus.
• Antibiotics, such as rifampicin, erythromycin, quinupristin or dalfopristin.
• Antidepressants, such as fluoxetine or nefazodone.
• Antifungals, such as ketoconazole, itraconazole or fluconazole.
• Antiretroviral medicines, such as indinavir, ritonavir, saquinavir, amprenavir, nelfinavir, delavirdine.
• Medicines that reduce stomach acid production, such as cimetidine.
• Cisapride.

It may be necessary to take special measures in case of radiological examination.

Using Adalat Oros with food, drinks and alcohol

• Do not drink alcoholic beverages at the same time as nifedipine.
• Do not drink grapefruit juice during treatment with nifedipine.

Pregnancy, breastfeeding and fertility

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

Driving and using machines

This medicine may limit your ability to drive or operate machinery, especially at the start of treatment.

Adalat Oros contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free". If your doctor increases your daily dose to 120 mg, this would result in a sodium intake of 37.6 mg, equivalent to 1.88% of the maximum daily recommended sodium intake for an adult.

3. How to take Adalat Oros

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

As a general rule, the tablet is taken without chewing with the help of a little liquid (which should not be grapefruit juice).

The Adalat Oros tablet should not be broken because it would lose its prolonged-release properties. Try to take the medicine at the same time every day.

Remember to take your medicine.

Your doctor will tell you how long to take nifedipine and what dose to start with. If you need to stop treatment, it is recommended to gradually reduce the dose.

As a general rule, the treatment regimen is one tablet once a day (in the morning). If higher doses are needed, your doctor will prescribe the dose you need.

Your doctor will prescribe the appropriate dose.

Special populations

Use in children and adolescents

Adalat Oros is not recommended for use in children and adolescents under 18 years of age, as the information on safety and efficacy in this population is limited.

Elderly patients (> 65 years)

No dose adjustment is required in elderly patients over 65 years of age.

Liver impairment

In patients with mild, moderate or severe liver problems, careful monitoring is required, and dose reduction may be necessary.

Kidney impairment

No dose adjustment is required in patients with kidney problems.

If you take more Adalat Oros than you should

Consult your doctor or pharmacist immediately, go to the nearest hospital or contact the Toxicology Information Service. Telephone: 91 562 04 20.

The main symptoms of overdose are: vomiting, cyanosis (bluish discoloration in distal areas, lips, hands, fingers, etc.), convulsions, sweating and cardiocirculatory collapse.

If you forget to take Adalat Oros

If you forget to take the medicine, you should take the dose as soon as you remember on the same day. Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects

(may affect up to 1 in 10 people):

• Headache.
• Oedema (swelling), vasodilation.
• Constipation.
• Feeling unwell.

Uncommon side effects

(may affect up to 1 in 100 people):

• Allergic reaction; allergic/oedematous angioedema (including laryngeal oedema with possible death).
• Anxiety reactions, sleep disturbances.
• Dizziness, migraine, dizziness, tremor.
• Visual disturbances.
• Tachycardia (increased heart rate), palpitations.
• Hypotension (low blood pressure), postural hypotension, syncope.
• Nasal bleeding, nasal congestion.
• Abdominal and gastrointestinal pain, nausea, dyspepsia (indigestion), flatulence, dry mouth.
• Alteration of liver function test results.
• Rash.
• Muscle cramps, joint swelling.
• Increased urination and difficulty urinating.
• Erectile dysfunction.
• Non-specific pain, chills.

Rare side effects

(may affect up to 1 in 1000 people):

• Pruritus, exanthema (skin rash), erythema (skin redness).
• Tingling sensation in the limbs, increased sensitivity to touch.
• Gingival hyperplasia (gum alteration).

Frequency not known

(cannot be estimated from the available data):

• Agranulocytosis, leucopenia (reduction of white blood cells).
• Anaphylactic/anaphylactoid reaction.
• Hyperglycaemia (alteration of blood glucose test).
• Hypoesthesia (reduced sensitivity to skin stimulation), somnolence.
• Ocular pain.
• Chest pain (angina pectoris).
• Dyspnoea (difficulty breathing).
• Bezoar, dysphagia (difficulty swallowing), intestinal obstruction, intestinal ulcer, vomiting, gastroesophageal sphincter insufficiency.
• Jaundice (yellowish skin discoloration).
• Exfoliative dermatitis, photosensitivity, allergic reaction, palpable purpura (alteration of certain blood parameters).
• Arthralgia (joint pain), myalgia (muscle pain).

In patients undergoing dialysis with malignant hypertension and hypovolemia, a significant decrease in blood pressure may occur due to vasodilation.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Adalat Oros

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

Store in the original packaging to protect from light and moisture.

Nifedipine is sensitive to light, therefore the tablets should not be broken and it is recommended to keep the tablet protected in the blister pack until the time of administration.

Do not use this medicine after the expiry date which is stated on the packaging after "EXP". The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Adalat Oros

The active substance is nifedipine. Each tablet contains 30 mg of nifedipine.

The other ingredients are polyethylene oxide, hypromellose, magnesium stearate, sodium chloride, red iron oxide (E-172), cellulose acetate, macrogol, hydroxypropylcellulose (E-463), propylene glycol (E-1520), titanium dioxide (E-171) and black iron oxide (E-172).

Appearance of the product and pack contents

Adalat Oros tablets are prolonged-release tablets, round, convex, pink, with the code Adalat 30 printed on one face and an orifice on one face. They are available in blister packs containing 28 or 500 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Manufacturer:

Bayer AG

Kaiser-Wilhelm-Allee

51368 Leverkusen

Germany

Date of last revision of this leaflet:November 2020

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)