Package leaflet: Information for the patient

Clopamid VP, 20 mg, tablets
Clopamidum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
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, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

What Clopamid VP is and what it is used for
What you need to know before taking Clopamid VP
How to take Clopamid VP
Possible side effects
How to store Clopamid VP
Contents of the pack and other information

1. What Clopamid VP is and what it is used for

Clopamid VP is a diuretic medicine belonging to the group known as thiazide-like diuretics. By increasing the excretion of water from the body, it reduces fluid retention (oedema).
The diuretic effect of Clopamid VP begins approximately 2 hours after oral administration, reaches its maximum within the next 1–4 hours, and lasts for about 24 hours after intake.
Clopamid VP is used in the treatment of oedema associated with heart failure, kidney disease, and liver disease.

2. Important information before using Clopamid VP

When not to use Clopamid VP

if the patient is allergic to clopamid or any of the other ingredients of this medicine (listed in section 6) or to sulfonamides
if the patient has severe renal impairment (creatinine clearance < 30 ml/min), acute glomerulonephritis, or anuria
if the patient has severe hepatic insufficiency or hepatic coma
if the patient has persistent conditions despite treatment: low blood potassium levels, increased blood calcium or uric acid levels, reduced vascular volume, significantly decreased blood sodium levels, or gout
if the patient has Addison's disease (deficiency of hormones produced by the adrenal glands)
if the patient has porphyria (disorders in the formation of a component of the red blood pigment, hemoglobin)
if the patient is pregnant or breastfeeding (see section: Pregnancy and breastfeeding).

Warnings and precautions
Before starting treatment with Clopamid VP, discuss this with your doctor, pharmacist, or nurse:

if the patient has impaired liver function or progressive liver disease
if the patient has impaired kidney function
if the patient is taking cardiac glycosides (see "Clopamid VP and other medicines")
if the patient has gout (Clopamid VP may increase blood uric acid levels and exacerbate the disease; therefore, the doctor may recommend additional blood tests)
if the patient has diabetes (Clopamid VP may increase blood glucose levels, which may require adjustment of antidiabetic medication dosage)
if the patient has elevated cholesterol or triglyceride levels
if the patient has severe atherosclerosis of coronary or cerebral vessels
if the patient has systemic lupus erythematosus
if the patient is elderly (in such individuals, the risk of electrolyte disturbances and dehydration is increased; therefore, they should exercise particular caution when using Clopamid VP and strictly follow the doctor's instructions)
if the patient experiences visual disturbances or eye pain. These may be symptoms of fluid accumulation in the vascular membrane surrounding the eye (excessive accumulation of fluid between choroid and sclera) or increased intraocular pressure – these may occur from several hours to weeks after taking Clopamid VP. If left untreated, they may lead to permanent vision loss. Patients who previously experienced allergy to sulfonamides or penicillin may be at increased risk of these adverse effects. Due to the possibility of photosensitivity, patients taking Clopamid VP should avoid prolonged exposure to sunlight.

Clopamid VP may lead to water and electrolyte imbalances. If during treatment with Clopamid VP the patient experiences any of the following symptoms: muscle cramps, weakness, drowsiness, low blood pressure, rapid heartbeat, thirst, or gastrointestinal symptoms, the doctor should be informed immediately. These may be signs indicating such disturbances.
During treatment with Clopamid VP, a strict low-sodium diet should be avoided. In long-term therapy, it is recommended to consume foods rich in potassium (dried fruits, legumes, fruits, fish, low-fat cheeses).

Clopamid VP and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
Especially inform your doctor or pharmacist if the patient is taking:

other medicines that may lower blood pressure, e.g. nifedipine, amlodipine, barbiturates, chlorpromazine, tricyclic antidepressants such as amitriptyline
lithium salts (used in the treatment of mood disorders)
cardiac glycosides (medicines used in heart diseases) – the doctor will recommend periodic ECG monitoring and blood potassium level checks
non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen, indomethacin, acetylsalicylic acid
anticoagulants, e.g. acenocoumarol
insulin (used in diabetes treatment)
medicines used for cardiac arrhythmias, such as amiodarone, disopyramide, quinidine, sotalol
calcium preparations
laxatives
steroids.

Taking Clopamid VP with food, drink, and alcohol
Clopamid VP can be taken independently of meals.
During treatment with Clopamid VP, alcohol consumption should not be excessive.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Clopamid VP is contraindicated during pregnancy and breastfeeding.

Driving and operating machinery
During the initial period of treatment with Clopamid VP, patients should not drive motor vehicles, operate mechanical equipment, or perform tasks requiring high psycho-physical alertness, as the medicine may cause dizziness or excessive fatigue during this phase of treatment.

3. How to use Clopamid VP

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Recommended dose:
Adults:
The initial dose, depending on the severity of symptoms, is 20 mg to 40 mg once daily, preferably in
the morning after a meal. If necessary, the doctor may increase the daily dose up to 60 mg. As
oedema symptoms subside, the dose will be gradually reduced. The maintenance dose is 10 mg to
20 mg daily or every other day.
Elderly patients (over 65 years of age):
Dose adjustment is not required.
Patients with liver or kidney function disorders:
This medicine must not be used in patients with severe renal or hepatic impairment.
Children and adolescents:
Due to insufficient data, use of this medicine is not recommended in this age group.
Clopamid VP should be taken regularly.
Taking more Clopamid VP than prescribed
If you take more Clopamid VP than recommended, the following may occur:
reduction in blood pressure upon changing position from sitting or lying to standing, or from lying to
sitting, accompanied by dizziness, visual disturbances (e.g. "blackouts") or fainting, nausea, vomiting,
dizziness, and disturbances in water and electrolyte balance (mainly decreased blood potassium
levels).
In case of overdose, consult your doctor immediately, who will initiate appropriate treatment.
Missing a dose of Clopamid VP
If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, skip
the missed dose. Take the next dose at the usual time. Do not take a double dose to make up for a
missed dose.
Stopping Clopamid VP
Stopping treatment with Clopamid VP may lead to worsening of the condition for which the medicine
was prescribed (e.g. increased oedema). Therefore, discontinuation of treatment should only be
done under medical supervision.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The frequency of occurrence of the adverse effects listed below is unknown (cannot be estimated
from the available data).

increased glucose levels, diabetes, activation of latent diabetes
decreased blood levels of potassium, magnesium, sodium and chlorides, increased blood calcium levels, increased blood uric acid levels with acute gout attack
increased blood cholesterol and triglyceride levels
dizziness, headache, drowsiness
fatigue
awareness of heartbeat (palpitations)
nausea, vomiting, diarrhoea, constipation, abdominal pain, dryness of the oral mucosa
skin redness
visual disturbances or eye pain due to elevated pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye – excessive fluid accumulation between choroid and sclera – or acute angle-closure glaucoma).

Generally, with the use of thiazide-type diuretics, the following may be reported: blood count abnormalities, including reduced platelet count (type of blood cells mainly responsible for stopping bleeding) and white blood cell count (type of blood cells primarily responsible for protecting the body against infections), hypersensitivity reactions (including lung inflammation, pulmonary oedema, severe skin reactions), orthostatic hypotension (drop in blood pressure upon changing position from lying down to standing or sitting), pancreatitis, intrahepatic cholestasis (bile stasis within the liver), allergic skin reactions, urticaria, photosensitivity, sexual dysfunction, impotence.
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 at 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
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 Clopamid VP

Keep in the original packaging.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
what to do with medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Clopamid VP contains

The active substance is clopamide. One tablet contains 20 mg of clopamide.
The other ingredients are: potato starch, microcrystalline cellulose, povidone, talc, magnesium stearate.

What Clopamid VP looks like and contents of the pack
Clopamid VP tablets are packed in Al/PVC blisters, with 20 tablets per blister. One blister, together with the package leaflet, is placed in a cardboard carton.

Marketing Authorisation Holder:
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer:
ICN Polfa Rzeszów S.A.
Przemysłowa 2 Street
35-105 Rzeszów, Poland
Tel. (48 17) 865 51 00