Package leaflet: information for the patient

IPOREL, 75 micrograms, tablets
Clonidini hydrochloridum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor. See section 4.

Leaflet contents:

What Iporel is and what it is used for
Important information before taking Iporel
How to take Iporel
Possible side effects
How to store Iporel
Contents of the pack and other information

1. What Iporel is and what it is used for

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

2. Important information before using Iporel

When not to use Iporel:

if the patient is allergic to the active substance (clonidine) or to any of the other
ingredients of this medicine (listed in section 6);
if the patient has bradycardia (slowed heart rate) due to sick sinus syndrome or second- or third-degree atrioventricular block;
in children under 12 years of age.

Warnings and precautions
Before starting treatment with Iporel, discuss it with your doctor.
Exercise special caution when using Iporel:

in patients with Raynaud's disease or other peripheral vascular disorders;
in patients with cerebral or coronary insufficiency;
in patients with mild or moderate bradycardia (severe bradycardia is a contraindication), such as slow sinus rhythm;
in patients with polyneuropathy (a disorder involving damage to peripheral nerves);
in patients with constipation.

During long-term treatment with Iporel, the doctor will carefully monitor patients
who are prone 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 is not effective in treating hypertension caused by pheochromocytoma (a type of adrenal gland tumor).
Clonidine, the active substance in Iporel, and its metabolites are primarily excreted in urine.
Patients with renal impairment may respond differently to clonidine. Therefore, careful dose adjustment for each patient and close monitoring by the doctor are necessary.
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 data on efficacy and safety in these patient groups.

Iporel and other medicines
Inform your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The effect of clonidine is enhanced by:

antihypertensive drugs: diuretics (water pills), vasodilators, β-blockers, calcium antagonists, and angiotensin-converting enzyme (ACE) inhibitors. However, the effect of α-adrenolytics is difficult to predict.

The hypotensive effect of clonidine is reduced by:

drugs that increase blood pressure or cause sodium (Na+) and water retention, such as nonsteroidal anti-inflammatory drugs (NSAIDs);
drugs blocking α-adrenergic receptors in a dose-dependent manner.

The antihypertensive effect of clonidine may be reduced or abolished by:

tricyclic antidepressants;
neuroleptics that block α-adrenergic receptors. These drugs may cause or worsen orthostatic hypotension.
Concomitant use of drugs that slow heart rate, such as β-blockers or cardiac glycosides, with clonidine increases the risk of developing or worsening certain cardiac arrhythmias.
Concomitant use of β-blockers with clonidine may also cause or worsen peripheral vascular disorders.
Clonidine may enhance the effects of substances that depress the central nervous system, including alcohol.

Pregnancy, breastfeeding, and fertility

During pregnancy, breastfeeding, or if pregnancy is suspected, or when planning pregnancy, consult a doctor or pharmacist before using this medicine.

Pregnancy
Clonidine crosses the placenta and may reduce fetal heart rate. A transient postnatal increase in blood pressure in the newborn cannot be excluded.
Iporel may be used during pregnancy only if, in the doctor's opinion, it is absolutely necessary. Close monitoring of both mother and child is recommended.

Breastfeeding
The use of Iporel during breastfeeding is not recommended due to lack of adequate data.
Clonidine passes into breast milk. The concentration in milk is nearly twice as high as in plasma.

Driving and operating machinery
This medicinal product may cause drowsiness, dizziness, and visual disturbances to an extent that may impair the ability to drive or operate machinery. Patients experiencing these symptoms should not drive or operate machinery.
The sedative effect caused by this medicinal product may be intensified when used concomitantly with other centrally acting depressant drugs.

3. How to take Iporel

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
The recommended dose is:

Initially, 1 tablet of 75 µg (micrograms) twice daily;
if necessary, your doctor may gradually increase the dose every second or third day until the optimal dose for the patient is reached. This usually ranges from 300 µg (4 tablets) to 1200 µg (16 tablets) per day. In some patients, higher doses may be required, e.g. 1800 µg (24 tablets) or even higher. Iporel may be introduced into treatment when the patient is already taking other antihypertensive medicines. In such cases, gradual reduction of the previously used medicines may be necessary. Clonidine may be used during the perioperative period and during general anaesthesia in patients undergoing surgical procedures.

Dosage in elderly patients
In elderly patients, dosage adjustment is not usually required compared to the standard dosage. Clinical studies have not shown specific adverse effects in this patient group.
Dosage in children and adolescents
The use of clonidine is not recommended in children and adolescents under 18 years of age due to insufficient data on safety and efficacy in this patient group.
Taking more Iporel than recommended
If symptoms of overdose occur, contact your doctor immediately.
Symptoms of overdose:
hypotension, bradycardia, drowsiness, irritability, weakness or loss of reflexes, miosis (pupil constriction), vomiting, and hypoventilation.
Large doses may cause cardiac arrhythmias, coma, respiratory arrest, seizures, and transient increase in blood pressure.
Treatment of overdose:
In most cases, no specific treatment is required beyond general supportive measures. In cases of severe bradycardia, atropine may be administered to increase heart rate.
If you miss a dose of Iporel
Do not take a double dose to make up for the missed dose.
Stopping Iporel treatment
Abrupt discontinuation of Iporel, especially in patients receiving high doses, may lead to rebound hypertension. Cases of anxiety, palpitations, nervousness, tremor, headache, and gastrointestinal symptoms have also been observed.
Do not stop treatment without consulting your doctor.
If discontinuation is necessary, the dose should be gradually reduced. However, if withdrawal symptoms occur, they may be managed by re-administering clonidine or using \α-adrenergic receptor blockers.
If Iporel is administered concomitantly with a -adrenolytic agent, Iporel should not be discontinued until several days after stopping the -adrenolytic agent.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
Adverse effects may occur with the following frequency:
very common: more than 1 in 10 people
common: 1 to 10 in 100 people
uncommon: 1 to 10 in 1,000 people
rare: 1 to 10 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, the following may occur in some patients:
drowsiness, dizziness, dry mouth.
These symptoms usually subside with continued treatment.

Other adverse effects.
Gastrointestinal disorders
Common: nausea and vomiting, constipation.
Frequency not known: loss of appetite, parotid gland inflammation, pseudo-obstruction of the large intestine.

Hepatic and biliary disorders
Frequency not known: transient increase in liver enzymes, liver damage.

Psychiatric disorders
Common: restlessness, nervousness, insomnia, malaise.
Frequency not known: depression, headache, nightmares, nocturnal anxiety, anxiety, hallucinations, other behavioural disorders.

Cardiac disorders
Common: orthostatic hypotension, palpitations, tachycardia or bradycardia.
Frequency not known: Raynaud's phenomenon, heart failure, cardiac arrhythmias, sinus bradycardia or atrioventricular block.

Skin and subcutaneous tissue disorders
Frequency not known: itching, rash, urticaria, alopecia, angioedema.

Reproductive system and breast disorders
Common: decreased sexual activity, impotence.

Renal and urinary disorders
Frequency not known: difficulty in urination, urinary retention.

General disorders and administration site conditions
Common: weakness, feeling of fatigue.
Frequency not known: weight gain.

Endocrine disorders
Frequency not known: gynaecomastia.

Musculoskeletal and connective tissue disorders
Frequency not known: muscle and joint pain, cramps in the lower limbs.

Dryness of the nasal mucous membrane and reduced tear secretion (important for contact lens wearers), as well as visual disturbances, have also been reported.

Fluid retention may occur in the initial stages of treatment. This is usually a transient condition, which can be corrected by adding a diuretic to the treatment.

The medicine may cause a transient increase in blood glucose levels during the initial phase of treatment.

If any adverse effects occur, including any possible adverse effects not listed in this leaflet, consult a doctor.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Iporel

Keep the medicine out of the sight and reach of children.
Store 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Iporel contains

The active substance is clonidine hydrochloride. Each 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 white or almost white, cream-tinted, round, biconvex tablets,
packed in blisters and cardboard boxes.
The pack contains 25 tablets or 50 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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