Adalat Oros 30 mg, prolonged-release tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Adalat Oros 30 mg, prolonged-release tablets

nifedipine

Package leaflet contents

1. What Adalat Oros is and what it is used for
2. What you need to know before taking 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

Adalat Oros tablet is an innovative prolonged-release system that functions as an osmotic pump, releasing nifedipine through a laser-drilled orifice in the tablet. Once the active substance has been completely released, the Adalat Oros tablet, which is non-deformable, is excreted intact in the feces.

The active substance, nifedipine, belongs to a group of medicines known as calcium antagonists. Drugs in this group dilate the coronary arteries, thereby increasing blood flow and improving oxygen supply to the heart. In addition, nifedipine dilates peripheral arterial vessels, which reduces elevated blood pressure.

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

2. What you need to know before starting Adalat Oros

Do not take Adalat Oros:

• if you are allergic to nifedipine or to 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 this medicine, especially:

• if you have hypotension (low blood pressure).

• if you suffer from gastrointestinal narrowing.

• if you regularly undergo dialysis, have malignant hypertension, severe kidney disease, or hypovolemia.

• if you have heart problems.

• if you have liver disease.

• in the case of in vitro fertilization, as Adalat Oros 30 may reduce the chances of conception.

• if you are taking other medicines (see section: ‘Other medicines and Adalat Oros’)

Additionally, inform your doctor before taking Adalat Oros if you have any of the following conditions:

• if you are scheduled for a radiological examination, as test results may be altered by treatment with this medicine.

Children and adolescents

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

Other medicines and Adalat Oros

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

Certain medicines may interact with Adalat Oros; in such cases, your doctor may need to adjust the dose or discontinue treatment with one of the medicines. This is especially important if you are 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.

Special precautions may be necessary during radiological examinations.

Use of Adalat Oros with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

Adalat Oros contains sodium

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

3. How to take Adalat Oros

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

Generally, the tablet should be swallowed whole with a little liquid (not grapefruit juice).

The Adalat Oros tablet must not be split, as this would destroy its prolonged-release properties. Try to take the medicine at the same time every day.

Remember to take your medicine.

Your doctor will determine the duration of treatment with nifedipine as well as the starting dose. If treatment needs to be discontinued, it is recommended to gradually reduce the dose.

As a general rule, the treatment regimen is one tablet once daily (in the morning). If higher doses are required, your doctor will prescribe the appropriate dose.

Your doctor will prescribe the correct dose for you.

Special populations

Use in children and adolescents

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

Hepatic impairment

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

Renal impairment

No dose adjustment is required in patients with kidney problems.

If you take more Adalat Oros than you should

Contact 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 of distal areas such as lips, hands, fingers, etc.), seizures, sweating, and cardiocirculatory collapse.

If you forget to take Adalat Oros

If you forget to take your dose, take it as soon as you remember on the same day. Do not take a double dose to make up for a missed dose.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Common adverse effects

(may affect up to 1 in 10 patients):

• Headache.
• Edema (swelling), vasodilation.
• Constipation.
• Feeling of malaise.

Uncommon adverse effects

(may affect up to 1 in 100 patients):

• Allergic reaction; allergic edema/angioedema (including laryngeal edema with possible fatal outcome).
• Anxiety reactions, sleep disturbances.
• Dizziness, migraine, vertigo, tremor.
• Visual disturbances.
• Tachycardia (increased heart rate), palpitations.
• Hypotension (low blood pressure), postural hypotension, syncope.
• Epistaxis (nosebleed), nasal congestion.
• Abdominal and gastrointestinal pain, nausea, dyspepsia (stomach heaviness, indigestion), flatulence, dry mouth.
• Abnormal liver function test results.
• Rash.
• Muscle cramps, joint swelling.
• Increased urinary secretion and difficulty in urination.
• Erectile dysfunction.
• Non-specific pain, chills.

Rare adverse effects

(may affect up to 1 in 1,000 patients):

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

Frequency not known

(cannot be estimated from available data):

• Agranulocytosis, leucopenia (decrease in white blood cells).
• Anaphylactic/anaphylactoid reaction.
• Hyperglycemia (abnormal blood glucose test).
• Hypoesthesia (reduced sensitivity to skin stimulation), somnolence.
• Eye pain.
• Chest pain (angina pectoris).
• Dyspnea (difficulty breathing).
• Bezoar, dysphagia (difficulty swallowing), intestinal obstruction, intestinal ulcer, vomiting, gastroesophageal sphincter insufficiency.
• Jaundice (yellowing of the skin).
• Exfoliative dermatitis, photosensitivity, allergic reaction, palpable purpura (alteration of certain blood parameters).
• Arthralgia (joint pain), myalgia (muscle pain).

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 it 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 until the time of administration.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This 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 components are polyethylene oxide, hypromellose, magnesium stearate, sodium chloride, iron oxide red (E-172), cellulose acetate, macrogol, hydroxypropylcellulose (E-463), propylene glycol (E-1520), titanium dioxide (E-171), and iron oxide black (E-172).

Appearance of the product and pack contents

Adalat Oros tablets are prolonged-release, round, convex, pink-colored tablets, with the code "Adalat 30" printed on one side and a hole on one side. They are available in blister packs containing 28 or 500 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Manufacturer:

Bayer AG
Kaiser-Wilhelm-Allee
51368 Leverkusen
Germany

Date of the most recent review of this leaflet: November 2020

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