Noclaud

Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Noclaud
100 mg, tablets
Cilostazol
Please read the entire leaflet carefully before taking this 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 questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

1. What Noclaud is and what it is 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 Noclaud is and what it is 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 dilation of certain blood vessels and reduction of clotting (aggregation) activity of certain blood cells called platelets within blood vessels.
Noclaud has been prescribed for the treatment of "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 a patient can walk without pain by improving blood circulation in the lower limbs.
Cilostazol is recommended only for 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 adhere to lifestyle modifications 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 high 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 this with your doctor or pharmacist

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

During treatment with Noclaud

• If surgery is required, including dental extractions, inform the doctor or dentist that you are taking Noclaud.
• If you notice an increased tendency to bruise or bleed, stop taking Noclaud and inform your doctor immediately.

Children and adolescents
Noclaud is not intended for use in children.
Noclaud and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken,
as well as any medicines you plan to take.
In particular, inform your doctor if you are taking certain medicines commonly used to treat
pain and (or) muscle or joint inflammation, or 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, your doctor may perform certain routine blood tests.
Some medicines taken simultaneously 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 treatment with Noclaud, inform your doctor if you are 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 remedy)

If you are unsure whether any of the above applies to medicines you are taking, consult your doctor or pharmacist.
Before starting treatment with Noclaud, the patient should inform the doctor if they are taking medicines for
high blood pressure, as Noclaud may cause an additional blood pressure-lowering effect. If blood pressure drops
too much, it 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; your doctor will decide
which treatment is appropriate for you.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant,
you should consult your 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, use tools, or
operate machinery. Inform your doctor or pharmacist if this occurs.

3. How to take Noclaud

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
you should consult your 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). Dose adjustment is not required in elderly patients. However, your doctor may prescribe a lower dose if the patient is taking medicines that may interact with 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.
Your doctor will assess the treatment efficacy after 3 months and may recommend discontinuation of
cilostazol therapy if the 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, adverse symptoms may occur,
such as severe headaches, diarrhoea, low blood pressure, and arrhythmia.
In case of overdose, seek immediate medical advice from a doctor or go to the nearest hospital.
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 scheduled 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 discontinued, pain in the lower limbs may return or worsen. Therefore,
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 must 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 illness with blisters on the skin, in the mouth, eyes, and genital area
• 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.
Certain 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
• runny nose (nasal catarrh)
• abdominal pain
• discomfort in the abdominal area (dyspepsia)
• nausea or vomiting
• loss of appetite (anorexia)
• excessive burping or passing wind (bloating with flatulence)
• swelling of ankles, feet, or face
• skin rash or skin appearance changes
• skin itching
• petechial skin bleeding (small red or purple spots due to bleeding under the skin)
• 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
• lung inflammation
• cough
• chills
• unexpected bleeding
• tendency to bleed (e.g. in the 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 soreness
• 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 1000 people)

• tendency to bleed longer than normal
• increased number of platelets in blood
• kidney problems

The following adverse reactions have been reported during treatment with cilostazol, but the frequency is unknown (frequency 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 in moving
• fever
• hot flushes
• skin rash and other skin eruptions
• reduced skin sensation
• watery or sticky eye discharge (conjunctivitis)
• ringing in the ears (tinnitus)
• liver problems, including hepatitis
• changes in urine

If any of the adverse reactions worsen, you should inform your doctor.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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 reactions can also be reported to the marketing authorisation holder or parallel importer.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Noclaud

No special storage instructions are required.
The medicine should be stored in a place out of 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 there are 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. This will help protect the environment.

6. Contents of the package and other information

What Noclaud contains

• The active substance is cilostazol. Each tablet contains 100 mg of cilostazol.
• 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, without any marking on the other side.
Packaging:
28 x (2 x 14), 56 x (4 x 14) tablets in PVC/PVDC/Al blisters, packed in a cardboard box with an enclosed patient information leaflet.
For more detailed information, please contact the responsible party 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:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
sp. k. ul. Forteczna 35-37 ul. Tymiankowa 24/28
ul. Działkowa 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
Marketing Authorisation Number in the Czech Republic, the country of export: 83/149/14-C
Parallel Import Authorisation Number: 417/24
The medicinal product is registered in the Member States of the European Economic Area under the following names:
Hungary Noclaud 100 mg tabletta
Czech Republic Noclaud
Latvia Sollazon 100 mg tabletes
Lithuania Sollazon 100 mg tabletės
Poland Noclaud