Patient Medication Information: uses, side effects, how to take - Zaditen (Teva Canada, Tablet)
What is Zaditen used for?
Zaditen is used with existing treatment to treat mild asthma caused by allergies in children (5 to 17 years of age).
How does Zaditen work?
Zaditen belongs to a group of medicines known as antihistamines. Zaditen works by blocking the allergic response. This helps reduce the symptoms of asthma.
What are the ingredients in Zaditen?
Medicinal ingredient: Ketotifen hydrogen fumarate.
Non-medicinal ingredients: Lactose monohydrate, magnesium stearate, and starch 1500.
Zaditen comes in the following dosage forms:
Tablets; 1 mg of ketotifen (as ketotifen hydrogen fumarate).
Do not use Zaditen if:
- you are allergic to ketotifen hydrogen fumarate or any of the other ingredients in Zaditen.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Zaditen. Talk about any health conditions or problems you may have, including if you:
are or are not currently receiving treatment for your asthma. This includes if you are taking:
- medicines known as beta-2 adrenergic agonists or corticosteroids, or
- medicines that contain ingredients known as xanthine derivatives or sodium cromoglycate.
If you are unsure, ask your healthcare professional.
- have sudden and severe symptoms of asthma attack such as cases of bronchospasms (when there is a sudden narrowing of the airway). An alternative treatment will be prescribed by your healthcare professional to relieve these symptoms.
- have ever had any fits or seizures in the past.
are pregnant or plan to become pregnant.
- are breast-feeding or plan to breast-feed. It is not known if Zaditen passes into breastmilk.
- have problems digesting certain sugars (e.g., lactose intolerance). Zaditen contains lactose, a milk sugar.
Other warnings you should know about:
Driving or using machines: Zaditen can cause drowsiness, especially after starting your treatment. You should not drive or use machines until you know how Zaditen affects you. Even then, you should engage in activities requiring rapid and precise responses with caution.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with Zaditen:
alcohol.
- antidiabetics, medicines used to treat diabetes.
- antihistamines, medicines used to treat allergies.
- hypnotics, medicines used to help with sleep and anxiety.
- sedatives, medicines used to help with sleep.
How to take Zaditen:
- Take Zaditen exactly as directed by your healthcare professional and continue with your existing asthma treatment.
- Zaditen is taken orally by mouth. Swallow Zaditen tablets whole.
- It may take a minimum of 2 to 3 months before you see a response to Zaditen. If you asthma worsens, you should contact your healthcare professional right away.
Usual dose:
Your healthcare professional will determine the right dose for you. This may depend on your condition and how you respond to Zaditen. The usual dose for children (5 to 17 years of age) is 1 tablet two times a day, once in the morning and once in the evening.
Your healthcare professional may decrease your dose throughout treatment. However, you must not stop or change your dose without first talking to your healthcare professional.
Overdose:
The symptoms of an overdose with Zaditen include:
- abnormally fast heartbeat,
- coma,
- confusion,
- disorientation,
- drowsiness to severe sedation,
- low blood pressure,
- seizures,
- easily or excessively excited.
| If you think you, or a person you are caring for, have taken too much Zaditen, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose:
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at your regularly scheduled time. Do NOT double your dose to make up for the missed dose.
What are possible side effects from using Zaditen?
These are not all the possible side effects you may have when taking Zaditen. If you experience any side effects not listed here, tell your healthcare professional.
Side effects of Zaditen include:
- dizziness,
- drowsiness,
- dry mouth,
- feeling excited,
- flu symptoms,
- increased appetite,
- trouble falling or staying asleep,
- irritability,
- nervousness,
- nose bleed,
- puffy eyelid,
- rash,
- sedation,
- sleeping problems,
- weight gain.
Serious side effects and what to do about them
| Symptom / effect | Talk to healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| COMMON | |||
| Respiratory infection: runny nose, sore throat, cough, common cold, sneezing, headaches, body aches, stuffy nose, runny nose, difficulty breathing, fever, or fatigue. | X | ||
| RARE | |||
| Cystitis (inflammation of the bladder): increased need to urinate, pain in the pelvis or lower back, frequent urination during the night, cloudy urine that may contain blood, or burning sensation when passing urine. | X | ||
| VERY RARE | |||
| Liver problems (including hepatitis): abdominal pain and swelling, fatigue, fever, itchiness, light coloured stool, trouble thinking clearly, yellowing of the skin and eyes, nausea, vomiting, unusual dark urine, or unusual tiredness. | X | ||
| Seizures (fit): loss of consciousness with uncontrollable shaking. | X | ||
| Severe skin reactions (including erythema multiforme and Stevens-Johnson syndrome): raised red or purple skin patches possibly with blister or crust in the center, swollen lips, mild itching, burning, redness, blistering of the skin, peeling of the skin, fever, chills, headache, cough, body aches, or swollen glands. | X | ||
| UNKNOWN FREQUENCY | |||
| Thrombocytopenia (low blood platelets): bruising or bleeding for longer than usual if you hurt yourself, fatigue, or weakness. | X | ||
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store Zaditen tablets below 25oC in a dry place.
Keep out of reach and sight of children.
If you want more information about Zaditen:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.tevacanada.com, or by calling 1-800-268-4127 ext. 5005.