Package leaflet: Information for the user

KCl-retard 600 mg prolonged-release tablets
Potassium chloride
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What KCl-retard is and what it is used for

KCl-retard contains an active substance called potassium chloride, which belongs to a class of medicines known as mineral supplements.
KCl-retard is indicated for preventing and correcting potassium deficiency in the body, which usually manifests as fatigue and muscle weakness (asthenia).
KCl-retard is used in situations where your body is in a state of potassium deficiency, such as when:

you are undergoing prolonged or intensive treatment with medicines called "diuretics", used to treat hypertension (high blood pressure) and oedemas (swellings) of various origins
you are taking medicines called "cardiac glycosides" to treat certain heart conditions
you are being administered potassium-free solutions
you are receiving high amounts of sodium salts (such as bicarbonate)
you are taking medicines called "corticosteroids" (medicines used to treat inflammation/allergies)
you abuse laxatives
you have repeated vomiting
you have severe diarrhoea
you have gastric, intestinal or biliary fistula (when parts of the stomach, intestine or bile ducts, which are normally separate, come into contact)
you suffer from hepatic cirrhosis (a serious chronic liver disease)
you have hyperfunction of the adrenal cortex (a condition causing hormonal imbalances)
you are under stressful conditions such as major surgical procedures or severe illnesses.

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking KCl-retard

Do not take KCl-retard

if you are allergic to potassium chloride or to any of the other ingredients of this medicine (listed in section 6).
if you have severe reduction in kidney function (renal failure)
if you have reduced urine output (oliguria)
if you have absence of urine output (anuria)
if you have increased nitrogen levels in the blood (hyperazotemia)
if you have hyperchloremic acidosis (a condition in which the acidity of body fluids increases) accompanied by hypokalemia (low potassium levels in the blood)
if you are being treated with a medicine called "carbonic anhydrase inhibitor" (a medicine used to treat eye diseases)
if you are in a state of acute dehydration (reduced amount of water in the body)
if you have hyperkalemia (increased potassium levels in the blood)
if you have Addison's disease (a condition causing severe reduction of certain hormones due to destruction of the gland that produces them).

Warnings and precautions
Talk to your doctor or pharmacist before taking KCl-retard.
The special structure of KCl-retard tablets has been designed to avoid the risk of irritation of the stomach and intestines; however, inform your doctor:

if you have esophageal compression (the organ connecting the pharynx to the stomach, which transports food to the stomach) due to heart problems (left atrial dilation)
if you have an obstruction of the gastrointestinal tract
if you have delayed gastrointestinal transit.

In addition, it is advisable to avoid:

concomitant administration of potassium salts and medicines called "potassium-sparing diuretics" (a group of medicines that act by increasing the amount of urine produced by the kidneys, such as aldosterone antagonists, triamterene, etc.), due to the risk of causing increased potassium levels in the blood.

If used for prolonged periods, your doctor will periodically monitor your potassium levels in the blood, especially if you have heart or kidney diseases.
Other medicines and KCl-retard
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions are currently known.
KCl-retard with food and drink
Take KCl-retard tablets after meals (see section 3 "How to take KCl-retard").
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Use this medicine only when strictly necessary and under direct medical supervision.
Driving and using machines
KCl-retard does not affect the ability to drive vehicles or operate machinery.
KCl-retard contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars (such as sucrose), contact him/her before taking this medicine.

3. How to take KCl-retard

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take the KCl-retard tablets after meals. Swallow the tablets whole, without chewing.

Adults
Generally, the recommended dose is 3–6 tablets per day; however, always follow the dose prescribed by your doctor.

If you take more KCl-retard than you should
If you accidentally take a large amount of this medicine, contact your doctor or go to the nearest hospital immediately.
In such cases, vomiting should be induced and gastric lavage performed (to be carried out in hospital).
Your doctor may also perform an electrocardiogram (ECG), a test to assess heart function. If ECG abnormalities occur, your doctor will check your blood potassium levels and, if necessary, initiate treatment with an appropriate solution.

If you forget to take KCl-retard
Do not take a double dose to make up for the missed tablet.

If you stop taking KCl-retard
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any of the following side effects during treatment with KCl-retard, contact your doctor immediately, who will DISCONTINUE treatment with KCl-retard:

severe vomiting
abdominal swelling and pain
gastrointestinal bleeding (bleeding from the stomach)

Other side effects have been reported with other medicines containing the same active substance as KCl-retard (potassium chloride), and therefore may also potentially occur with KCl-retard:

Frequency not known (cannot be estimated based on available data)

narrowing (stenosis) of the small intestine (the first part of the intestine)
intestinal ulceration (intestinal lesions)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You may also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store KCl-retard

Keep this medicine out of the sight and reach of children.
Do not store above 30°C. Protect the medicine from heat and moisture.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What KCl-retard contains

The active substance is: potassium chloride 600 mg
The other components are: cetyl stearyl alcohol, gelatin, magnesium stearate, spray-dried gum arabic, titanium dioxide, sucrose granulated (see section “KCl-retard contains sucrose”), purified special talc, yellow iron oxide, red iron oxide, carnauba wax.

Description of the appearance of KCl-retard and pack contents
KCl-retard is available as 600 mg tablets, packaged in blisters, with 40 tablets per carton.

Marketing Authorization Holder
Teofarma S.r.l.

Manufacturer
Delpharm L’Aigle – ZI n. 1 Secteur Ouest Route de Crulai – 61300 L’Aigle, France
or
Teofarma S.r.l.
Viale Certosa, 8/A
27100 Pavia, Italy
or
Dragenopharm Apotheker Püschl GmbH
Göllstrasse 1
84529 Tittmoning
Germany