NIFEDIPINE LM 20 Dilution 10 ml

NIFEDIPINE, treat heart diseases, high blood pressure indication

The drug is used to treat heart diseases associated with insufficient oxygen supply to the heart muscle and to treat high blood pressure.

The drug is used in

Symptoms (e.g. pain or tightness in the chest area) in conditions with insufficient oxygen supply to the heart muscle (angina pectoris):

under stress: chronically stable angina pectoris (stress angina)

due to vasospasm: vasospastic angina pectoris (Prinzmetal s angina, variant angina)

non-organic hypertension

hypertensive crisis

Notice:

In patients with non-organ related hypertension or chronic angina pectoris treated with nifedipine immediate-release formulations (this preparation is one of them), there is evidence of a dose-dependent increase in cardiovascular complications (e.g. myocardial infarction) and an increase resulting in mortality. Therefore, the drug should only be used in these two diseases if other drugs are not indicated.

NIFEDIPINE, treat heart diseases, high blood pressure dosage

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Treatment should be individualized as much as possible, depending on the severity of the disease and the patient s response.

Depending on the clinical picture in question, the recommended dose should be gradually reached.

Patients with severe problems with blood flow to the brain (cerebrovascular disease) should be treated with a lower dose.

An adjustment of the nifedipine dose may be necessary if other medicinal products that inhibit or enhance a certain enzyme system (cytochrome P450 3A4) are used concomitantly.

dosage

Unless otherwise prescribed by the doctor, the usual dose for adults is:

Coronary heart disease

high blood pressure

10 – 20 drops 3 times a day (equivalent to 30 – 60 mg nifedipine per day).

The maximum daily dose is 60 mg nifedipine.

hypertensive crisis

If necessary, 10 drops (equivalent to 10 mg nifedipine).

If there is no or insufficient effect, another dose of 10 mg nifedipine can be given after about 30 minutes at the earliest. With shorter intake intervals and or higher doses, dangerous reductions in blood pressure can occur.

Use in specific patient groups

children and young people

The medicine is not recommended for use in children and adolescents under 18 years of age as there is limited data on safety and efficacy in this age group.

Elderly patients

For maintenance therapy, elderly patients may require a lower dose than younger patients.

Patients with impaired liver function

Patients with hepatic impairment should be carefully monitored and a dose reduction may be necessary.

Patients with impaired renal function

Dose adjustment is not required in these patients.

duration of use

The doctor treating you determines the duration of the intake.

Please talk to your doctor or pharmacist if you have the impression that the effect is too strong or too weak.

If you take more than you should

An overdose of the drug can lead to a severe drop in blood pressure, slower or faster heart rate, clouding of consciousness to the point of complete unconsciousness, increased blood sugar levels (hyperglycaemia), reduced blood flow to important organs and shock caused by heart failure with accumulation of fluid in the lungs (pulmonary oedema).

If you suspect an overdose, contact a doctor emergency doctor immediately so that he can decide how to proceed.

If you forget to take a dose

Do not take a double dose to make up for a forgotten dose.

If you stop taking it

Please do not interrupt or stop treatment with the medicine without first discussing this with your doctor.

Discontinuation of treatment with the preparation – especially at high doses – should be done gradually.

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

NIFEDIPINE, treat heart diseases, high blood pressure way

To take

The drops are taken after meals with sufficient liquid (e.g. 1 glass of water), preferably in the morning, at noon and in the evening, if possible at the same time.

The medicine must not be taken with grapefruit juice.

If you are taking single doses of more than 20 mg nifedipine, you should leave a gap of at least 2 hours between single doses.

Due to the photosensitivity of the active ingredient nifedipine, the solution must be taken immediately after removing it from the bottle.

side NIFEDIPINE, treat heart diseases, high blood pressure effects

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

The frequency of side effects is based on the following categories:

very common: more than 1 in 10 people treated

common: affects 1 to 10 users in 100

uncommon: affects 1 to 10 users in 1,000

Rare: affects 1 to 10 users in 10,000

very rare: affects less than 1 in 10,000 people

not known: frequency cannot be estimated from the available data

possible side effects

Diseases of the blood and lymphatic system

Rare: Changes in the blood picture such as a reduction in the number of red or white blood cells or blood platelets (anaemia, leukopenia, thrombocytopenia), bleeding from the skin and mucous membranes with a reduced number of blood platelets (thrombocytopenic purpura).

Very rare: Severe reduction in the number of certain white blood cells (agranulocytosis).

diseases of the immune system

Uncommon: Allergic reactions, allergic tissue swelling, swelling of the face and mucous membranes in the mouth and throat (angioedema) including laryngeal swelling, which can be life-threatening. itching, rash.

Rare: hives.

Frequency not known: Acute general allergic reactions that may be life-threatening under certain circumstances (anaphylactic anaphylactoid reactions).

Psychiatric Illnesses

Uncommon: anxiety reactions, sleep disorders.

Metabolic and nutritional disorders

Rare: increase in blood sugar levels.

Diseases of the nervous system

Very common: headache.

Common: dizziness, lightheadedness, weakness.

Uncommon: migraine, muscle tremors, abnormal sensations (e.g. tingling, furry feeling), sometimes painful. Drowsiness fatigue, nervousness.

Frequency not known: Decreased sensitivity to touch stimuli.

eye diseases

Uncommon: visual disturbances.

Frequency not known: eye pain.

heart diseases

Common: palpitations.

Uncommon: increased heart rate, chest pain (angina pectoris). Occasionally, attacks of angina pectoris may occur, particularly at the beginning of treatment, or in patients with existing angina pectoris, the frequency, duration and severity of attacks may increase. The occurrence of a heart attack has been described in isolated cases.

Very rare: myocardial infarction.

vascular diseases

Very common: Tissue swelling due to fluid retention.

Common: dilatation of blood vessels (e.g. flushing of the face).

Uncommon: drop in blood pressure, fainting for a short time.

Respiratory, thoracic and mediastinal disorders

Uncommon: Nosebleeds, nasal congestion, shortness of breath.

Digestive tract diseases

Common: constipation, nausea.

Uncommon: gastrointestinal pain, abdominal pain, indigestion, flatulence, dry mouth.

Rare: overgrowth of gums, loss of appetite, feeling of fullness, belching.

Frequency not known: vomiting, esophagitis.

Liver and biliary diseases

Uncommon: Transient increase in liver enzymes.

Rare: jaundice.

Skin and subcutaneous tissue disorders

Common: painful swelling and redness of the arms and legs (erythromelalgia), especially at the beginning of treatment. Sweat.

Uncommon: reddening of the skin with a feeling of warmth.

Rare: Allergic photosensitivity of the skin. Palpable, small-spotted hemorrhages in the skin and mucous membrane.

Very rare: scaly skin inflammation (exfoliative dermatitis).

Frequency not known: Serious and life-threatening skin changes with detachment and blistering of the epidermis (scalded skin syndrome, toxic epidermal necrolysis).

Musculoskeletal, connective tissue and bone disorders

Uncommon: muscle cramps, swollen joints, muscle pain.

Frequency not known: joint pain.

Diseases of the kidneys and urinary tract

Uncommon: Increased urge to urinate and increased daily urine output. Painful urge to urinate with difficulty in urinating. In the case of renal insufficiency, a temporary deterioration in renal function is possible.

Diseases of the genital organs and the mammary gland

Uncommon: erectile dysfunction.

Rare: Enlargement of the male breasts (gynaecomastia) that disappear after stopping the drug.

General disorders and administration site conditions

Common: General malaise.

Uncommon: Non-specific pain, chills.

A significant drop in blood pressure can occur in dialysis patients with high blood pressure and reduced blood volume.

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

NIFEDIPINE, treat heart diseases, high blood pressure interactions

When taking the preparation with other medicines

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

What other medicines affect the way this medicine works?

Nifedipine (the active ingredient in this medicine) is broken down with the participation of a specific enzyme system (cytochrome P450 3A4). Therefore, the concomitant use of drugs that affect this enzyme system can, in principle, lead to interactions of these drugs with the preparation.

Both the extent and duration of interactions should be considered if the drug is to be taken with the drugs listed below.

Weakening of the effect of other medicines:

Phenytoin (active substance used to treat cardiac arrhythmias and epilepsy): Reduces the effectiveness of nifedipine. If both drugs are taken at the same time, the reaction to nifedipine (the active ingredient in this drug) should be observed and an increase in the dose of this drug should be considered if necessary. After stopping the use of phenytoin, the dose of nifedipine may need to be adjusted again.

Carbamazepine and phenobarbital (active substances used to treat epilepsy): Taking this medicine at the same time can lead to a weakened effect of the preparation.

Rifampicin (anti-tuberculosis medicine): Causes the body to break down nifedipine (the active ingredient in this medicine) more quickly. Rifampicin must not be used concomitantly with treatment with nifedipine, since effective blood levels of nifedipine are not achieved.

Enhancement of the nifedipine effects and side effects by other drugs:

If you are using the following other medicines concomitantly with this product, blood pressure should be monitored and a reduction in the dose of Nifedipine ratiopharm 20 mg ml considered, if necessary:

Certain antibiotics (e.g. erythromycin)

fluoxetine and nefazodone (anti-sad mood remedies, antidepressants)

Ritonavir (anti-HIV medicine)

Certain antifungal medicines (e.g. ketoconazole)

Quinupristin Dalfopristin (antibiotics)

cimetidine (medicine against stomach and intestinal ulcers)

valproic acid (anti-epilepsy medicine)

tricyclic antidepressants (medicines for depression)

vasodilators (medicines that dilate blood vessels)

cisapride (drug that speeds up bowel movement)

How does this preparation affect the effects of other medicines?

Antihypertensive drugs:

The blood pressure-lowering effect of other medicines of different active substance groups can be increased by this preparation, e.g. B. from:

Diuretics (water pills)

beta-receptor blockers (medicines for high blood pressure)

ACE inhibitors (medicines for high blood pressure)

angiotensin receptor antagonists (medicines for high blood pressure)

other calcium antagonists (medicines for high blood pressure)

alpha-receptor blockers (medicines for high blood pressure and heart failure)

PDE 5 inhibitors (medicines to treat erectile dysfunction)

Alpha-methyldopa (medicine for high blood pressure)

In the case of simultaneous treatment with beta-receptor blockers (active substance group of antihypertensive drugs), signs of heart failure may occasionally occur. Your doctor will carefully monitor the course of treatment in these cases.

Digoxin (active ingredient to strengthen the heart), theophylline (active ingredient to widen the bronchi): The concentration of these medicines in the blood may increase. Signs of digoxin overdose should be observed and, if necessary, the digoxin dose reduced by the doctor (after determining the digoxin concentration in the blood).

Vincristine (active ingredient for the treatment of tumours): The excretion of vincristine is reduced, which can increase the side effects of vincristine. Your doctor may prescribe a reduction in the dose of vincristine.

Cephalosporins (drugs used to treat infections): levels of cephalosporins in the blood may be increased.

Quinidine (active substance for the treatment of cardiac arrhythmias): In individual cases, the preparation causes a drop in the quinidine content in the blood or the discontinuation of nifedipine causes a significant increase (control of the quinidine content in the blood!). In other cases, quinidine has also been reported to increase blood levels of nifedipine. It is therefore recommended that blood pressure is carefully monitored when both drugs are used concomitantly. If necessary, the dose of this medicine should be reduced.

Tacrolimus (active ingredient to prevent transplant rejection after e.g. liver and kidney transplants): If nifedipine is taken at the same time, increased tacrolimus blood levels may occur, so that the tacrolimus dose should be reduced in individual cases. Regular monitoring of tacrolimus blood levels is recommended.

Magnesium sulfate (intravenous): When co-administered with nifedipine, an excessive fall in blood pressure may occur.

Take with food, drink and alcohol

Grapefruit juice can increase the blood pressure lowering effect of this medicine. This effect lasts for at least 3 days after the last ingestion of grapefruit juice. Consuming grapefruit or grapefruit juice should therefore be avoided in connection with the nifedipine treatment.

NIFEDIPINE, treat heart diseases, high blood pressure Contraindications

The drug must not be taken

if you are allergic to nifedipine or any of the other ingredients of this medicine

if you have been in shock

if you suffer from narrowing of the heart valves (aortic stenosis).

if you have symptoms (e.g. pain or tightness in the chest) at rest in conditions with insufficient oxygen supply to the heart muscle (angina pectoris).

if you have had an acute heart attack within the last 4 weeks

if you are taking medicines containing the active substance rifampicin (medicines for tuberculosis) at the same time

pregnancy NIFEDIPINE, treat heart diseases, high blood pressure and breast feeding period

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

A harmful drug effect on the unborn child and the infant cannot be ruled out. Therefore, you should not use the drug during pregnancy. Any use during pregnancy should only be done after a very careful individual benefit-risk assessment and should only be considered if all other treatment options are unsuitable or have proven to be ineffective.

If treatment with the drug is necessary during breast-feeding, it is recommended to wait 3-4 hours after taking the drug, as nifedipine (the active ingredient in this drug) passes into breast milk and there is no experience of possible effects on the infant.

In individual cases, the drug can impair sperm function. If repeated artificial insemination is unsuccessful, nifedipine should be considered as a possible cause.

patient NIFEDIPINE, treat heart diseases, high blood pressure notes

Warnings and Precautions

Please talk to your doctor or pharmacist before taking this medicine.

Treatment with the preparation requires regular medical supervision

if you have low blood pressure (systolic below 90 mmHg).

if you suffer from insufficiently treated heart muscle weakness (decompensated heart failure).

if you are a dialysis patient with severe high blood pressure and reduced circulating blood volume, as a significant drop in blood pressure may occur

if you are pregnant or breastfeeding

Taking the drug can cause an excessive drop in blood pressure with an accelerated heartbeat (reflex tachycardia), which can lead to cardiovascular problems.

Attacks of angina pectoris may occasionally occur, particularly at the beginning of treatment, or an increase in the frequency, duration and severity of attacks in patients with existing angina pectoris.

Heart attacks have been reported very rarely.

The active substance in this medicine, nifedipine, is broken down with the participation of a specific enzyme system (cytochrome P450 3A4). This enzyme system can be inhibited or increased by other medicines. This can change the effects and side effects of the drug

If you take the medicine at the same time as other medicines that inhibit this enzyme system, this can result in increased effects, but also increased side effects of the medicine. These include e.g. B. the following medicines:

certain antibiotics (e.g. erythromycin)

certain anti-HIV medicines (e.g. ritonavir)

certain antifungal medicines (e.g. ketoconazole)

Nefazodone and fluoxetine (anti-sad mood remedies, antidepressants)

Quinupristin Dalfopristin (antibiotics)

valproic acid (anti-epilepsy medicine)

cimetidine (medicine against stomach and intestinal ulcers)

If the drug is used concomitantly with any of these drugs, blood pressure should be monitored and a reduction in the nifedipine dose considered, if necessary.

For use in special patient groups, see category Dosage .

Ability to drive and use machines

Treatment with this drug requires regular medical supervision. Due to the different reactions that occur individually, the ability to react can be changed to such an extent that the ability to actively participate in road traffic, to operate machines or to work without a secure footing is impaired. This applies to a greater extent at the start of treatment, when the dose is increased and when the drug is changed, as well as in combination with alcohol.

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