ZENTEL 400 mg. 1 tablet

WHAT IS A ZENTEL AND WHAT IT IS USED
Zentel is used to treat infections caused by various parasites, including roundworms, trichuria trihyuria, tapeworms, hookworms. They usually infect the intestines but can cause changes in other parts of the body.
Zentel works by stopping the absorption of sugar (glucose) from parasites and their larvae, thus losing energy and dying. The medicine also works against their eggs.

How parasitic infections occur
Infection occurs when drinking water or eating foods containing eggs or larvae of parasites. They grow in the gut. Because there may be little or no symptoms in the early stages of the infection, one may not know it is infected.
Signs and symptoms depend on the type of infection, but may include abdominal pain, nausea, diarrhea, anemia and tiredness. Some infections can cause problems in other parts of the body such as liver, lungs or brain.
The parasites that remain in the intestine can easily be cured. Some, however, move to other parts of the body and it is important to treat them as soon as possible. This will help prevent permanent disabilities. Some of the non-treated infections can be life-threatening.

Protect yourself from parasitic infections
It is important to follow the advice below to protect yourself from future infections, to transmit infections to others, and to become infected again while taking Zentel:
Wash your hands with soap and water after walking to the lavatory, after touching animals and before eating;
Before eating make sure that the meat is properly prepared and that the fruits and vegetables are washed with clean water.
2. BEFORE YOU TAKE A CENTER
Do not take Zentel:
If you are allergic (hypersensitive) to albendazole or any of the other ingredients of Zentel (listed in section 6);
If you are pregnant, think you are pregnant or if you are planning to become pregnant (see Pregnancy and breast-feeding in section 2).
If you think any of these things apply to you, do not take Zentel until you have been consulted by your doctor.

Observe the appearance of important symptoms

Seizures and other symptoms
Patients treated for parasitic infections may also have a rare and serious brain infection called neurocysticercosis, and they do not always know about it. There is a reaction when the parasites die in the brain. Symptoms include seizures, headaches and vision problems. For more information, see Section 4 Conditions to Keep Track of.

Blood tests for long-term treatment with high doses of Zentel
Zentel can lead to:
Reducing the number of blood cells produced by the body;
An increase in hepatic enzyme levels in the blood produced by the liver. Your doctor may order blood tests to check the number of blood cells and liver enzymes before and during treatment. Depending on the results, you may need to stop or discontinue treatment.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Some medicines may affect the action of Zentel or increase the likelihood of side effects. These are:
Cimetidine (used to treat stomach ulcers);
Praziquantel (used to treat some parasitic infections);
Dexamethasone (used to treat inflammation or allergy);
Ritonavir (used to treat HIV infection);
Phenytoin, carbamazepine or phenobarbital, used to treat seizures and epilepsy.
Tell your doctor or pharmacist if you are taking any of these medicines.

Pregnancy and breastfeeding
Do not take Zentel if you are pregnant, think you are pregnant or if you are planning to become pregnant.
If you become pregnant while taking Zentel, contact your doctor immediately.

Zentel can harm an unborn baby. For short-term low-dose treatment to avoid taking Zentel during an early pregnancy, take Zentel only during the first week of the menstrual cycle or after a negative pregnancy test.
For prolonged high dose treatment:
Take Zentel only after a negative pregnancy test. Before starting a new course of Zentel, you must re-test your pregnancy test.
Use a reliable method of contraception to protect yourself from becoming pregnant while taking Zentel and one month after completing treatment.
Driving and using machines
Zentel has no influence on the ability to drive and use machines. However, caution should be exercised when driving and operating machines at the start of the drug.

3. HOW TO ACCEPT A ZENTEL 
How much Zentel to take
Always take Zentel exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The doctor will determine the appropriate dosage of Zentel and the duration of your treatment (or your child). The dosage depends on your body weight, age, and the type and severity of the infection.

How to take Zentel
Swallow the tablets with water. Some people, especially young children, may have difficulty swallowing the tablets whole. In these cases, the tablets may be chewed with a little water or crushed.

Short-term low-dose treatment
It is recommended that you take Zentel at the same time each day, with or without food.

Prolonged treatment with high doses
It is recommended that you take Zentel at the same time each day, with food or immediately after a meal.

If you forget to take Zentel
If you have missed a dose, take the medicine as soon as you remember. Take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you are not sure, ask your doctor or pharmacist.

If you take more Zentel than you should
If you take too much Zentel, talk to your doctor or pharmacist for advice. If possible, show them Zentel's packaging.

Do not stop taking Zentel without a doctor's recommendation
Take Zentel for as long as your doctor has recommended. Do not stop taking the medicine unless your doctor advises you.
It is extremely important to turn the full course of treatment with Zentel.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Zentel can cause side effects, although not everyone gets them.

Conditions you should be following
Seizures and other symptoms
Patients treated for parasitic infections may also have a rare and serious disease called neurocysticercosis, which is characterized by the presence of parasites in the brain. When Zentel is taken into the brain, a reaction occurs after the killing of the parasites. Keep an eye on the following symptom combination:
Headache, which can be severe;
nausea and vomiting;
Seizures;
Vision problems.
Tell your doctor immediately if you experience these symptoms.

Short-term low-dose treatment
Uncommon side effects
They may affect up to 1 in 100 patients:
Headache or vertigo;
Vomiting or nausea, stomach pain or diarrhea.
Rare side effects
They may affect up to 1 in 1,000 patients:
Skin rash;
Itching.
Rare side effects that may occur in your blood tests:
Elevated liver enzymes.
Very rare side effects
They may affect up to 1 in 10,000 patients:

Severe skin rashes:
A skin rash that can form bubbles and looks like small targets (central dark spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme);
Generalized rash with blistering and peeling skin, especially around the mouth, nose and genital organs (Stevens-Johnson syndrome).
Tell your doctor immediately if you notice any of these symptoms.

Prolonged treatment with high doses
Very common side effects
They may affect more than 1 in 10 patients:
headache.
Very common side effects that may occur in your blood tests:
Elevated liver enzymes.
Common side effects
They may affect up to 1 in 10 patients:
Vertigo;
stomachache;
Nausea;
Vomiting;
Fever;
Reversible hair thinning and moderate hair loss (alopecia).
Uncommon side effects
They may affect up to 1 in 100 patients:
Inflammation of the liver (hepatitis);
Skin rash, pruritus.
Uncommon side effects that may occur in your blood tests:
Decrease in the number of white blood cells (leucopenia).
Very rare side effects
They may affect up to 1 in 10,000 patients:
Severe skin rashes
A skin rash that can form bubbles and looks like small targets (central dark spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme);
Generalized rash with blistering and peeling skin, especially around the mouth, nose and genital organs (Stevens-Johnson syndrome).
Tell your doctor immediately if you notice any of these symptoms.

Very rare side effects that may occur in your blood tests:
Decreasing the number of red blood cells, white blood cells and cells responsible for blood clotting (platelets) called pancytopenia;
Reduction in the number of all types of blood cells (agranulocytosis);
Inability of the bone marrow to produce new red or white blood cells (aplastic anemia).
If you get side effects
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE ZENTEL
Keep out of the reach and sight of children.
Do not use Zentel after the expiry date which is stated on the blister and pack. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of your unnecessary medicines. These measures will help to protect the environment.

6. ADDITIONAL INFORMATION
What does Zentel contain?
The active substance is albendazole. Each tablet contains 400 mg albendazole.
The other ingredients are: lactose, microcrystalline cellulose, corn starch, croscarmellose sodium, povidone sodium, sodium lauryl sulfate, sunset yellow lacquer, sodium saccharin, magnesium stearate, vanilla flavor, flavor of maracchia, orange flavor.

What Zentel looks like and what the package contains
Zentel tablets are pale orange, rounded, oblong, biconvex tablets with a line on one side and engraved with "ALB 400" on the reverse with a characteristic fruity aroma.
Zenel 400 mg tablets are available in blister packs containing 1 tablet or 100 tablets (1 blister tablet) and plastic containers containing 60 tablets.
Not all pack sizes may be marketed.

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