Noclaud

Package leaflet: Information for the patient

Warning! Keep the leaflet – the information on the immediate packaging is in a foreign language!
Noclaud
100 mg, tablets
Cilostazol
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• Consult your doctor or pharmacist if you have any doubts.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse effects, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Noclaud and what is it used for

Noclaud contains the active substance cilostazol and belongs to a group of medicines called phosphodiesterase type 3 inhibitors. It produces various effects, including widening certain blood vessels and reducing the clotting activity (aggregation) of certain blood cells called platelets within blood vessels.
Noclaud has been prescribed to treat "intermittent claudication". Intermittent claudication is cramp-like pain in the lower limbs occurring during walking, caused by insufficient blood flow to the legs. Noclaud increases the distance the patient can walk without experiencing pain by improving blood circulation in the lower limbs.
Cilostazol should be recommended only to patients in whom lifestyle modifications (including smoking cessation and increased exercise intensity) and other appropriate interventions have not sufficiently alleviated symptoms. It is important that the patient continues to maintain the recommended lifestyle changes during treatment with cilostazol.

2. Important information before using Noclaud

When not to use Noclaud

• if the patient is allergic to cilostazol or any of the other ingredients of this medicine (listed in section 6),
• if the patient has heart failure,
• if the patient experiences chest pain at rest or has had a heart attack or any heart surgery within the last six months,
• if the patient has currently or previously experienced a brief loss of consciousness due to heart disease or any severe heart rhythm disorders,
• if the patient has been diagnosed with a condition that increases the risk of bleeding or bruising, such as:
  • active peptic ulcer,
  • stroke within the last six months,
  • diabetic eye disease,
  • poorly controlled blood pressure.
• treatment with both acetylsalicylic acid and clopidogrel, or any combination of two or more medicines that may increase the risk of bleeding [if in doubt, consult a doctor or pharmacist],
• if the patient has severe kidney disease or moderate to severe liver disease,
• if the patient is pregnant.

Warnings and precautions
Before starting treatment with Noclaud, discuss with your doctor or pharmacist:

• if the patient has severe heart disease or any heart-related problems,
• if the patient has blood pressure problems.

While being treated with Noclaud:

• If surgery is required, including dental procedures such as tooth extraction, inform the doctor or dentist that the patient is taking Noclaud.
• If the patient develops a tendency to bruise easily or experiences bleeding, stop taking Noclaud and inform the doctor immediately.

Children and adolescents
Noclaud is not intended for use in children.

Noclaud with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor about medicines commonly used to treat pain and/or muscle or joint inflammation, and medicines that reduce blood clotting. These include:

• acetylsalicylic acid
• clopidogrel
• anticoagulants (e.g. warfarin, dabigatran, rivaroxaban, apixaban or low molecular weight heparins).

If these medicines are taken together with Noclaud, the doctor may perform certain routine blood tests.
Some medicines taken at the same time may interfere with the action of Noclaud. They may increase the side effects of Noclaud or reduce its effectiveness. Similarly, Noclaud may affect the action of other medicines. Before starting Noclaud, inform the doctor if the patient is taking:

• erythromycin, clarithromycin or rifampicin (antibiotics)
• ketoconazole (used to treat fungal infections)
• omeprazole (used to treat increased stomach acid)
• diltiazem (used to treat high blood pressure or chest pain)
• cisapride (used for stomach disorders)
• lovastatin, simvastatin or atorvastatin (used to treat high blood cholesterol)
• halofantrine (used to treat malaria)
• pimozide (used to treat psychiatric disorders)
• ergot derivatives (used to treat migraine, e.g. ergotamine, dihydroergotamine)
• carbamazepine or phenytoin (used to treat seizures)
• St John’s wort (herbal preparation)

If in doubt whether any of the above applies to medicines the patient is taking, consult a doctor or pharmacist.
Before starting Noclaud, the patient should inform the doctor if they are taking medicines for high blood pressure, because Noclaud may cause an additional blood pressure-lowering effect. Excessive lowering of blood pressure may lead to a rapid heartbeat. These medicines include:

• diuretics (e.g. hydrochlorothiazide, furosemide)
• calcium channel blockers (e.g. verapamil, amlodipine)
• ACE inhibitors (e.g. captopril, lisinopril)
• angiotensin II receptor blockers (e.g. valsartan, candesartan)
• beta-blockers (e.g. labetalol, carvedilol)

It may still be acceptable to use the above-mentioned medicines together with Noclaud. The doctor will decide which treatment is appropriate for the patient.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Noclaud MUST NOT be used during pregnancy.
Noclaud is NOT RECOMMENDED for use in breastfeeding mothers.

Driving and operating machinery
Noclaud may cause dizziness. If dizziness occurs after taking Noclaud, DO NOT drive, operate tools, or use any machinery. Inform your doctor or pharmacist if this occurs.

3. How to use Noclaud

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.

• The recommended dose is 2 x 100 mg (two 50 mg tablets or one 100 mg tablet) twice daily (morning and evening). No dose adjustment is required for elderly patients. However, the doctor may prescribe a lower dose if the patient is taking medicines that may affect the action of Noclaud.
• Noclaud should be taken 30 minutes before breakfast and dinner. Tablets should always be taken with water.

Some benefits of using Noclaud may become noticeable after 4–12 weeks of treatment.
The doctor will assess the treatment effectiveness after 3 months and may recommend discontinuation of cilostazol therapy
if the treatment response is insufficient.
Use in children and adolescents
Noclaud is not intended for use in children.
Taking more Noclaud than recommended
If for any reason a patient takes more Noclaud tablets than prescribed, symptoms such as severe
headache, diarrhoea, low blood pressure and irregular heart rhythm may occur.
In case of overdose, contact a doctor or the nearest hospital immediately. Remember to bring the
packaging along so it is clear which medicine has been taken.
Missing a dose of Noclaud
There is no cause for concern if a dose is missed. Wait and take the next dose at the usual time, then continue taking the medicine as directed. DO NOT take a double dose to make up for a missed tablet.
Stopping Noclaud
If treatment with Noclaud is stopped, pain in the lower limbs may return or worsen. For this reason, Noclaud should only be discontinued if adverse reactions occur that require urgent medical attention (see section 4) or on the advice of a doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the symptoms listed below occur, urgent medical attention may be required.
You should immediately stop taking Noclaud and contact your doctor or go to the nearest hospital.

• stroke
• heart attack
• heart problems which may cause breathlessness or ankle swelling
• irregular heartbeat (new or worsening symptom)
• noticeable bleeding
• easy bruising
• severe blistering illness affecting the skin, mouth, eyes, and genitals
• yellowing of the skin or whites of the eyes due to liver or blood disorders (jaundice)

You should also inform your doctor immediately if you develop fever or sore throat.
Blood tests may be necessary, and your doctor will decide on further treatment.
The following adverse reactions have been reported with cilostazol. You should inform your doctor
as soon as possible if any of these occur:

Very common adverse reactions (may affect more than 1 in 10 people)

• headache
• abnormal stools
• diarrhoea

Common adverse reactions (may affect up to 1 in 10 people)

• fast heartbeat
• palpitations
• chest pain
• dizziness
• sore throat
• nasal congestion (rhinitis)
• abdominal pain
• abdominal discomfort (dyspepsia)
• nausea or vomiting
• loss of appetite (anorexia)
• excessive belching or passing wind (bloating with flatulence)
• swelling of ankles, feet, or face
• rash or skin changes
• skin itching
• petechial skin bleeding
• general weakness

Uncommon adverse reactions (may affect up to 1 in 100 people)

• heart attack
• irregular heart function (new or worsening symptom)
• heart disorders which may cause breathlessness or ankle swelling
• pneumonia
• cough
• chills
• unexpected bleeding
• tendency to bleed (e.g. in stomach, eye, or muscles, nosebleeds, and presence of blood in sputum or urine)
• decreased number of red blood cells in blood
• dizziness upon standing
• fainting
• anxiety
• sleep disturbances
• nightmares
• allergic reaction
• muscle pain and tenderness
• diabetes and increased blood sugar levels
• stomach pain (gastritis)
• malaise

In patients with diabetes, there may be an increased risk of bleeding into the eye.
Rare adverse reactions (may affect up to 1 in 1,000 people)

• prolonged bleeding tendency
• increased number of platelets in blood
• kidney problems

The following adverse reactions have been reported during treatment with cilostazol, but the frequency is unknown (cannot be estimated from the available data):

• changes in blood pressure
• decreased number of red blood cells, white blood cells, and platelets in blood
• difficulty breathing
• difficulty moving
• fever
• hot flushes
• rash and other skin eruptions
• reduced skin sensation
• watery or sticky eye discharge (conjunctivitis)
• tinnitus (ringing in the ears)
• liver problems, including hepatitis
• changes in urine

If any of the adverse reactions worsen, you should inform your doctor or pharmacist.
Reporting of adverse reactions
If you experience any adverse reactions, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Reporting adverse reactions helps to provide more information on the safe use of the medicine.

5. How to store Noclaud

No special storage instructions are required.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not use this medicine if you notice any visible signs of deterioration (e.g. fading).
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the packaging and other information

What Noclaud contains

• The active substance is cilostazol. Each tablet contains 100 mg of cilostazol.
• The other ingredients are: microcrystalline cellulose, corn starch, calcium carmellose, hypromellose 2910, and magnesium stearate.

What Noclaud looks like and contents of the pack
Appearance: Odourless or almost odourless, white or almost white, round, flat tablets with bevelled edges. The tablets are embossed on one side with a stylized letter E and the number 602, with no marking on the other side.
Pack: 28 (2 x 14) or 56 (4 x 14) tablets in PVC/PVDC/Al blisters, packed in a cardboard box with an instruction leaflet.

For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in the Czech Republic, the country of export:
Egis Pharmaceuticals PLC
Keresztúri út 30-38.
1106 Budapest
Hungary

Manufacturer:
Egis Pharmaceuticals PLC
Bökényföldi út 118-120
1165 Budapest
Hungary

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź

Marketing Authorisation number in the Czech Republic, the country of export: 83/149/14-C
Parallel Import Licence number: 270/22

The medicinal product is registered in the European Economic Area countries under the following trade names:
Hungary Noclaud 100 mg tabletta
Bulgaria Ноклауд 100 mg таблетки
Czech Republic Noclaud
Latvia Sollazon 100 mg tabletes
Lithuania Sollazon 100 mg tabletės
Poland Noclaud
Romania Noclaud 100 mg comprimate
Slovakia Noclaud 100 mg