Package Insert: Information for the User

Adalat Oros 30 mg, prolonged-release tablets

nifedipine

The Adalat Oros tablet is an innovative prolonged-release system that acts as an osmotic pump that releases nifedipine through a hole drilled into the tablet by laser technology. Once the active ingredient is fully dispersed, the Adalat Oros tablet, which is non-deformable, is excreted entirely in the feces.

The active ingredient, nifedipine, belongs to a series of medications known as calcium antagonists. Medications in this group dilate coronary arteries, increasing blood flow and improving oxygen supply to the heart. On the other hand, nifedipine dilates peripheral arterial vessels, reducing elevated blood pressure.

Adalat Oros is indicated for the treatment of high blood pressure, chronic stable angina (effort angina) and Raynaud's syndrome.

Do not take Adalat Oros:

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

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

Warnings and precautions

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

• if you have hypotension (low blood pressure).
• if you have gastrointestinal constriction.
• 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 decrease the chances ofconception.

conception.

- in case of being used with other medications (see section: ‘Other medications and AdalatOros’)

Inform your doctorbefore taking Adalat Oros if you have any of these conditions:

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

Children and adolescents

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

Other medications and Adalat Oros

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

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

• Other medications to lower high blood pressure; such as diltiazem.
• Cardiotonic medications, such as digoxin.
• Antiepileptic medications, such as phenytoin, phenobarbital or carbamazepine; valproic acid.
• Antiarrhythmic medications, such as quinidine.
• Immunosuppressive medications, such as tacrolimus.
• Antibiotics, such as rifampicin, erythromycin, quinupristin or dalfopristin.
• Antidepressants, such as fluoxetine or nefazodone.
• Antifungal medications, such as ketoconazole, itraconazole or fluconazole.
• Antiretroviral medications, such as indinavir, ritonavir, saquinavir, amprenavir, nelfinavir, delavirdine.
• Medications that reduce stomach acid production, such as cimetidine.
• Cisapride.

It may be advisable to take special precautions in case of a radiological examination.

Use of Adalat Oros with food, drinks and alcohol

- Do not take alcoholic beverages at the same time as nifedipine.

- Do not take grapefruit or grapefruit juice during treatment with nifedipine.

Pregnancy, breastfeeding and fertility

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

Driving and operating machinery

This medication may limit your ability to drive cars or operate machinery, especially at the beginning of treatment.

Adalat Oros contains sodium

This medication 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 sodium intake recommended for an adult.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The tablet is usually taken without chewing with a little liquid (not grapefruit juice).

Do not break the Adalat Oros tablet because it would lose its prolonged-release properties. Try to take the medication every day at the same time.

Remember to take your medication.

Your doctor will indicate the duration of treatment with nifedipine as well as the dose with which you should start. If you need to discontinue 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 required dose.

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 old, as safety and efficacy information in this population is limited.

Older Adults (> 65 years)

No dose adjustment is required in older adults over 65 years old.

Liver Impairment

In patients with mild, moderate, or severe liver problems, careful monitoring should be performed, and a 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

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

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

If You Forget to Take Adalat Oros

If you forget to take the medication, take the dose as soon as you remember on the same day. Do not take a double dose to compensate for the missed dose.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Frequent side effects

(may affect up to 1 in 10 patients):

• Headache.
• Swelling (edema), vasodilation.
• Constipation.
• Unpleasant sensation.

Less frequent side effects

(may affect up to 1 in 100 patients):

• Allergic reaction; allergic edema/angioedema (including laryngeal edema with risk of death).
• Anxiety reactions, sleep disturbances.
• Dizziness, migraine, vertigo, 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 (heaviness in the stomach, indigestion), flatulence, dry mouth.
• Alteration of liver function test results.
• Rash.
• Muscle cramps, joint swelling.
• Increased urine production and difficulty urinating.
• Erectile dysfunction.
• Non-specific pain, chills.

Rare side effects

(may affect up to 1 in 1000 patients):

• Itching, exanthema (skin rash), erythema (skin redness).
• Tickling sensation in the extremities, increased sensitivity to touch.
• Gingival hyperplasia (alteration of the gums).

Unknown frequency

(cannot be estimated from available data):

• Agranulocytosis, leucopenia (decreased white blood cell count).
• Anaphylactic/anaphylactoid reaction.
• Hyperglycemia (alteration of blood glucose test).
• Hypoesthesia (decreased sensitivity to cutaneous stimulation), somnolence.
• Eyestrain.
• Chest pain (angina pectoris).
• Dyspnea (difficulty breathing).
• Bezoar, dysphagia (difficulty swallowing), intestinal obstruction, intestinal ulcer, vomiting, gastroesophageal sphincter insufficiency.
• Ictericia (yellow discoloration of the skin).
• Dermatitis exfoliativa, 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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication 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 pack until the time of administration.

Do not use this medication after the expiration date that appears on the packaging 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 the packaging and medications that you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Adalat Oros

The active ingredient 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 contents of the packaging

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

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Responsible manufacturer:

Bayer AG

Kaiser-Wilhelm-Allee

51368 Leverkusen

Germany

Last review date of this leaflet:November 2020

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