Iporel

Package Leaflet: Information for the Patient

IPOREL, 75 micrograms, tablets

Clonidine hydrochloride

Table of Contents of the Leaflet:

• 1. What is Iporel and what is it used for
• 2. Important information before taking Iporel
• 3. How to take Iporel
• 4. Possible side effects
• 5. How to store Iporel
• 6. Contents of the pack and other information

1. What is Iporel and what is it used for

The active substance of Iporel is clonidine. Its effect on the autonomic nervous system leads to vasodilation and a decrease in arterial blood pressure. Iporel is used to treat primary and secondary hypertension of all severity degrees.

2. Important information before taking Iporel

When not to take Iporel:

• in children under 12 years of age.

Warnings and precautions

Before starting treatment with Iporel, the patient should discuss it with their doctor.

Special caution should be exercised when taking Iporel:

• in patients with Raynaud's disease or other peripheral vascular diseases;
• in patients with cerebral or coronary insufficiency;
• in patients with mild or moderate bradycardia (severe is a contraindication) such as slow sinus rhythm;
• in patients with polyneuropathy (peripheral nerve damage syndrome);
• in patients with constipation.

It is necessary to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the patient should consult a doctor.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor. See section 4.

During long-term treatment with Iporel, the doctor will carefully monitor patients with a tendency to depression, as cases of depression have been reported in patients treated with clonidine. If the patient has heart failure, the doctor will monitor them particularly closely. Iporel does not have a therapeutic effect in hypertension due to pheochromocytoma (a type of adrenal gland tumor). Clonidine, the active substance of Iporel, and its metabolites are mainly excreted in the urine. Patients with renal insufficiency may react differently to the effect of clonidine. Therefore, it is necessary to carefully adjust the dosage for each patient and monitor them closely. Only a minimal amount of clonidine is removed during dialysis, so there is no need to administer additional clonidine after dialysis.

Children and adolescents

Iporel should not be used in children and adolescents under 18 years of age due to insufficient knowledge about the efficacy and safety of the medicine in these patients.

Iporel and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The following medicines enhance the effect of clonidine:

• medicines used to treat hypertension: diuretics, vasodilators, beta-adrenergic blockers, calcium antagonists, and angiotensin-converting enzyme (ACE) inhibitors. The effect of alpha-adrenergic blockers is difficult to predict.

The following medicines weaken the hypotensive effect of clonidine:

• medicines that increase blood pressure or cause sodium and water retention, such as non-steroidal anti-inflammatory drugs;
• medicines that block alpha-adrenergic receptors in a dose-dependent manner.

The following medicines weaken or abolish the antihypertensive effect of clonidine:

• tricyclic antidepressants;
• neuroleptics that block alpha-adrenergic receptors. These medicines may cause or exacerbate orthostatic hypotension.

Concomitant administration of clonidine with medicines that slow heart rate, such as beta-adrenergic blockers or digitalis glycosides, increases the risk of certain arrhythmias. It cannot be excluded that concomitant use of beta-adrenergic blockers with clonidine may cause or exacerbate peripheral vascular diseases. Clonidine may enhance the effect of substances with a depressant effect on the central nervous system, including alcohol.

Pregnancy, breastfeeding, and fertility

In pregnancy, during breastfeeding, or if pregnancy is suspected, or if the patient is planning to become pregnant, they should consult a doctor or pharmacist before taking this medicine. Pregnancy Clonidine crosses the placenta and may cause a decrease in fetal heart rate. It cannot be excluded that there may be a postpartum transient increase in blood pressure in the newborn. The medicine can be used in pregnant women only if, in the doctor's opinion, it is absolutely necessary. Close monitoring of the mother and child is recommended. Breastfeeding The use of Iporel during breastfeeding is not recommended due to the lack of appropriate data. Clonidine passes into breast milk. The concentration in milk is almost twice as high as in plasma.

Driving and using machines

The medicinal product may cause drowsiness, dizziness, and visual disturbances to the extent that it impairs the ability to drive vehicles and operate machines. Patients experiencing these symptoms should not drive or operate machines. The sedative effect of the medicinal product may be enhanced by concomitant use of medicines with a depressant effect on the central nervous system.

3. How to take Iporel

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult a doctor or pharmacist. The recommended dose is:

• initially 1 tablet of 75 µg (micrograms) twice a day;
• if necessary, the doctor may gradually increase the dose of the medicine every other or every third day to the optimal dose for the patient, which usually ranges from 300 µg (4 tablets) to 1200 µg (16 tablets) per day. In some patients, it may be necessary to use higher doses, e.g., 1800 µg (24 tablets) or even higher. Iporel can be introduced into treatment when the patient is already taking other antihypertensive medicines. In such cases, it may be necessary to gradually reduce the dose of the previously used medicines. Clonidine can be used during the perioperative period and during general anesthesia in patients undergoing surgical procedures.

Dosage in elderly patients

In elderly patients, there is no need to adjust the dosage compared to the usual dosage. Clinical trials have not shown any specific adverse reactions in this group of patients.

Dosage in children and adolescents

The use of clonidine is not recommended in children and adolescents under 18 years of age due to the lack of sufficient data on the use of the medicine in this group of patients.

Overdose of Iporel

If symptoms of overdose occur, the patient should contact their doctor. Symptoms of overdose: hypotension, bradycardia, drowsiness, irritability, weakness or loss of reflexes, miosis, vomiting, and hypoventilation. Large doses may cause arrhythmias, coma, and apnea, seizures, and transient hypertension. Treatment of overdose: in most cases, no treatment is required other than general supportive measures. In cases of severe bradycardia, atropine may be used to increase heart rate.

Missed dose of Iporel

The patient should not take a double dose to make up for a missed dose.

Withdrawal of Iporel

Sudden withdrawal of Iporel, especially in patients receiving high doses, may cause rebound hypertension. Cases of anxiety, palpitations, nervousness, tremors, headache, and gastrointestinal symptoms have also been observed. The patient should not stop treatment without consulting their doctor. If it is necessary to discontinue the medicine, the dose should be gradually reduced. However, if withdrawal symptoms occur, they can be alleviated by re-administering clonidine or alpha and beta-adrenergic blockers. If Iporel is administered concomitantly with a beta-adrenergic blocker, the patient should not discontinue Iporel until a few days after discontinuing the beta-adrenergic blocker.

4. Possible side effects

Like all medicines, Iporel can cause side effects, although not everybody gets them. Side effects may occur with the following frequencies: very common: more than 1 in 10 people; common: 1 in 10 to 1 in 100 people; uncommon: 1 in 100 to 1 in 1,000 people; rare: 1 in 1,000 to 1 in 10,000 people; very rare: less than 1 in 10,000 people; frequency not known: frequency cannot be estimated from the available data.

At the beginning of treatment, some patients may experience:

drowsiness, dizziness, dry mouth. These symptoms usually disappear as treatment continues.

Other side effects.

Gastrointestinal disorders
Common: nausea and vomiting, constipation.
Frequency not known: anorexia, parotid gland inflammation, pseudo-obstruction of the large intestine.
Hepatobiliary disorders
Frequency not known: transient elevation of liver enzymes, liver damage.
Psychiatric disorders
Common: agitation, nervousness, insomnia, malaise.
Frequency not known: depression, headache, nightmares, nocturnal anxiety, anxiety, hallucinations, other behavioral disorders.
Cardiac disorders
Common: orthostatic hypotension, palpitations, tachycardia or bradycardia.
Frequency not known: Raynaud's phenomenon, heart failure, arrhythmias, sinus bradycardia or atrioventricular block.
Skin and subcutaneous tissue disorders
Frequency not known: pruritus, rash, urticaria, alopecia, angioedema.
Reproductive system and breast disorders
Common: decreased sexual activity, impotence.
Renal and urinary disorders
Frequency not known: urinary retention, urinary difficulties.
General disorders and administration site conditions
Common: weakness, fatigue.
Frequency not known: weight gain.
Endocrine disorders
Frequency not known: gynecomastia.
Musculoskeletal and connective tissue disorders
Frequency not known: muscle and joint pain, muscle cramps in the lower limbs.
There have also been reports of dryness of the nasal mucosa and decreased tear secretion (important for contact lens wearers), visual disturbances. Fluid retention may occur in the initial phases of treatment. This is usually a transient condition that can be corrected by adding a diuretic to the treatment. The medicine may cause a transient increase in blood sugar levels in the initial phase of treatment. If the patient experiences any side effects, including any not listed in this leaflet, they should consult their doctor.

Reporting of side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Iporel

The medicine should be stored out of sight and reach of children. Store in a temperature below 25°C. Do not use this medicine after the expiry date stated on the blisters and carton after EXP. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Iporel contains

• The active substance of Iporel is clonidine hydrochloride. One tablet contains 75 micrograms of clonidine hydrochloride.
• The other ingredients are: calcium hydrogen phosphate dihydrate, potato starch, povidone K-25, magnesium stearate.

What Iporel looks like and contents of the pack

Iporel is a white or almost white tablet with a creamy tint, round, biconvex, packaged in blisters and cardboard boxes. The pack contains 25 tablets or 50 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland, Tel: +48 17 865 51 00

Manufacturer

Przedsiębiorstwo Farmaceutyczne Jelfa SA, ul. Wincentego Pola 21, 58-500 Jelenia Góra, Poland, Bausch Health Poland sp. z o.o., ul. Przemysłowa 2, 35-959 Rzeszów, Poland

Date of last revision of the leaflet: