10 mg film-coated tablet
hydroxyzine hydrochloride
What Hydroxyzine Bluefish is and what it is used for
Hydroxyzine Bluefish suppresses certain functions in the brain without being addictive and blocks histamine, a substance found in the body’s tissues. In this way, it has an effect against anxiety, itching, and hives.
Hydroxyzine Bluefish is used to treat:
- anxiety in adults
- itching and hives.
In case of anxiety, the effect is felt after about 15 minutes and lasts for about 12 hours. With itching and hives, the effect is reached after about 1 hour and lasts at least 24 hours.
Hydroxizine contained in Hydroxyzine Bluefish may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Hydroxyzine Bluefish
Do not take Hydroxyzine Bluefish:
- if you are allergic to hydroxyzine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
- if you are allergic to cetirizine, aminophylline, ethylenediamine or piperazine derivatives (closely related substances in other medicines).
- if you suffer from porphyria (a metabolic disease).
- if you are pregnant or breast-feeding (see “Pregnancy, breast-feeding and fertility”).
- if your ECG ( electrocardiogram ) shows a type of heart problem called prolonged QT interval .
- if you have or have had a cardiovascular disease or if you have a very slow heart rhythm.
- if you have low salt levels in your body (eg low potassium or magnesium ).
- if you are taking certain medicines for heart rhythm problems or medicines that can affect your heart rhythm (see “Other medicines and Hydroxyzine Bluefish”).
- if someone in the family has died suddenly of heart problems.
Warnings and cautions
Talk to your doctor or pharmacist before taking Hydroxyzine Bluefish:
- if you have a kidney disease or a liver disease or if you are older. You may need a lower dose .
- if you are at greater risk of having seizures (seizures).
- if you have any risk factors for stroke .
- if you have increased pressure in the eye ( glaucoma ).
- if you have obstructions in the urinary system.
- if you have constipation (slow bowel function).
- if you have pronounced muscle weakness ( myasthenia gravis ).
- if you have mental disorders (dementia).
Hydroxyzine Bluefish can cause an increased risk of heart rhythm problems which can be life-threatening. Therefore, tell your doctor if you have any heart problems or if you are taking any other medicines, including medicines obtained without a prescription.
Contact your healthcare provider immediately if you experience heart problems such as palpitations, difficulty breathing, or unconsciousness while taking Hydroxyzine Bluefish. Treatment with hydroxyzine should be discontinued.
Dry mouth can be a side effect when using Hydroxyzine Bluefish. It is therefore important to maintain good oral hygiene during treatment with Hydroxyzine Bluefish.
If you are going to have an allergy test, treatment with Hydroxyzine Bluefish should be stopped at least 5 days before the test. Ask your doctor for advice.
Caution should be exercised if you are older. The treatment time should be as short as possible.
Other medicines and Hydroxyzine Bluefish
Tell your doctor or pharmacist if you have recently taken or might take any other medicines, including medicines obtained without a prescription. Hydroxyzine Bluefish may affect or be affected by other medicines.
Do not take Hydroxyzine Bluefish if you are taking medicines to treat:
- bacterial infections (eg antibiotics; erythromycin, moxifloxacin, levofloxacin).
- fungal infections (eg pentamidine).
- heart problems or high blood pressure (eg amiodarone , quinidine , disopyramide , sotalol).
- psychosis is (eg haloperidol ).
- depression (eg citalopram , escitalopram).
- gastrointestinal disorders (eg prucalopride).
- allergy .
- malaria (eg meflokin).
- cancer (eg toremifene, vandetanib).
- drug abuse or severe pain ( methadone ).
Also, tell your doctor if you are taking:
- betahistine used to treat Meniere’s disease (balance and hearing problems).
- medicines used to treat anxiety or to help you sleep.
- anticholinergic drugs for the treatment of e.g. IBS (irritable bowel syndrome) and asthma .
- cimetidine used to treat stomach upset. It can increase the level of Hydroxyzine Bluefish in the blood.
- Monoamine oxidase inhibitors ( MAOIs ) used to treat depression and Parkinson’s disease .
- thiazide diuretics (used to treat high blood pressure , for example ). These may increase the risk of irregular heartbeat.
Hydroxyzine Bluefish with food, drink and alcohol
You should avoid alcohol while taking Hydroxyzine Bluefish as this combination may potentiate the effects of Hydroxyzine Bluefish and thus increase the risk of side effects.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Hydroxyzine Bluefish should not be used during pregnancy.
Hydroxyzine, the active substance in Hydroxyzine Bluefish, passes to the fetus. There is a risk that the fetus is affected.
Hydroxyzine Bluefish should not be used during breastfeeding.
If treatment with Hydroxyzine Bluefish is necessary during breast-feeding, breast-feeding should be discontinued as hydroxizine passes into breast milk.
Driving and using machines
Hydroxyzine Bluefish may impair your ability to drive and use machines and may cause drowsiness, diminish your attention and impair your ability to react. You are most likely to be affected by this at the beginning of treatment or when your dose is increased. Do not drive or use machines if you experience any of these effects.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Hydroxyzine Bluefish contains lactose
Hydroxyzine Bluefish tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Hydroxyzine Bluefish film-coated tablets contain sodium
This medicine contains less than 1 mmol (23 mg) sodium per 10 mg tablet, ie essentially ‘sodium-free.
How to take Hydroxyzine Bluefish
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dose one is determined by the doctor, who adjusts it individually for you.
Hydroxyzine Bluefish should be used at the lowest effective dose and for the shortest possible treatment time.
The recommended dose is:
Hives and itching:
Adults and adolescents (12 years and older):
25-50 mg (1-2 tablets of 25 mg) in the evening. The maximum daily dose for adults and adolescents weighing more than 40 kg is 100 mg per day.
Children aged 5-12 years:
10-25 mg (1 tablet of 10 mg or 1 tablet of 25 mg) in the evening.
The maximum daily dose for children weighing over 40 kg is 100 mg per day.
The maximum daily dose for children weighing up to 40 kg is 2 mg/kg/day.
If you / your child needs a dose lower than 10 mg or if you / your child have difficulty swallowing tablets, other medicines containing hydroxyzine may be more appropriate. The 10 mg tablet cannot be divided into two equal doses. Talk to a doctor.
Anxiety
Adults:
10 mg – 50 mg (1-5 tablets of 10 mg or 1-2 tablets of 25 mg), 2-3 times daily. The maximum daily dose for adults over 40 kg is 10 tablets of 10 mg or 4 tablets of 25 mg (100 mg daily).
Treatment of anxiety with medication should always be a supportive measure. Do not change dose one without first talking to your doctor.
Elderly patients:
In elderly patients, it is recommended to start with half the recommended dose due to a prolonged effect. The maximum daily dose for the elderly is 50 mg per day.
Patients with kidney problems
The dose should be reduced in patients with moderate or severe kidney problems.
Patients with liver problems
In patients with hepatic impairment, it is recommended to reduce the daily dose by one.
Use for children and adolescents
Hydroxyzine Bluefish is only for the treatment of hives and itching in adolescents and children from 5 years of age.
If you take more Hydroxyzine Bluefish than you should
If you have ingested too much medicine or if e.g. a child inadvertently ingested the medicine immediately contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. In the event of an overdose, symptomatic treatment may be initiated. ECG monitoring can be performed due to the risk of heart rhythm problems such as prolonged QT intervals or Torsade de Pointes .
If you forget to take Hydroxyzine Bluefish
Do not take a double dose to make up for a forgotten tablet.
4. Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
Stop taking this medicine and contact your healthcare provider immediately if you get:
- heart rhythm problems such as palpitations, difficulty breathing or unconsciousness. (Has been reported, occurs in an unknown number of users).
- swelling of the face, lips, tongue and / or throat, sometimes accompanied by difficulty breathing or difficulty swallowing ( angioedema ). (Very rare, may affect up to 1 in 10,000 users).
- widespread rash with blisters ( acute generalized exanthematous pustulosis ), annular, red rash, often with blisters – usually on the hands and feet (erythema multiforme), inflammation of the mucous membranes and skin in combination with high fever ( Stevens-Johnson syndrome). (Very rare, may affect up to 1 in 10,000 users).
Other side effects that may occur:
Very common (may affect more than 1 user in 10):
- somnolence.
Common (may affect up to 1 in 10 people):
- headache,
- drowsiness,
- dry mouth ,
- fatigue.
Uncommon (may affect up to 1 in 100 people):
- concern,
- confusion,
- dizziness,
- insomnia,
- tremors,
- nausea,
- fever.
Rare (may affect up to 1 in 1,000 people):
- allergic reactions (hypersensitivity),
- disorientation, hallucinations (see things that do not exist),
- seizures, involuntary movements ( dyskinesia ),
- problems focusing the eye, blurred vision,
- low blood pressure ,
- constipation,
- vomiting,
- elevated liver enzyme levels ( transaminases , alkaline phosphatase, bilirubin and glutamyl),
- itching , hives, red rash, marks or blisters, inflammation of the skin ( dermatitis ),
- difficulty urinating.
- cardiac arrest, effects on heart rhythm, irregular heartbeat.
Very rare (may affect up to 1 in 10,000 people):
- anaphylactic shock (severe allergic reaction ),
- respiratory tract contractions ( bronchospasm ),
- increased sweating.
Has been reported (occurs in an unknown number of users):
decreased platelet count ( thrombocytopenia ),
- aggressiveness,
- Depression,
- repeated involuntary muscle twitches ( tics ),
- abnormal elongated muscle contractions ( dystonia ),
- feeling of tickling, tingling or numbness ( paresthesia ),
- fainting,
- uncontrolled circulatory eye movements (oculogyration),
- diarrhea,
- bedwetting or difficulty urinating (abnormal urinary excretion),
- extreme weakness ( asthenia ),
- tissue swelling due to fluid retention ( edema ),
- weight gain.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Hydroxyzine Bluefish
Keep this medicine out of the sight and reach of children.
Blister: No special temperature instructions.
Jar: No special temperature instructions.
Store in the original package. Moisture sensitive.
Do not use this medicine after the expiry date which is stated on the carton, blister and jar after EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is hydroxyzine hydrochloride 10 mg.
- The other ingredients are microcrystalline cellulose, lactose monohydrate , croscarmellose sodium, colloidal anhydrous silica, talc, magnesium stearate, hypromellose, macrogol 400, titanium dioxide (E171).
What the medicine looks like and contents of the pack
White to off-white round biconvex film-coated tablet.
Blister:
25, 30, 84, 100 and 250 tablets
Jar with childproof lid:
25, 30, 84 and 100 tablets.
Jar with polypropylene lid:
250 tablets
The pack of 250 tablets is for dose dispensing.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bluefish Pharmaceuticals AB
PO Box 49013
100 28 Stockholm
Manufacturer
Bluefish Pharmaceuticals AB
Gävlegatan 22
113 30 Stockholm
This medicinal product is authorized under the European Economic Area under the names:
| Sweden | Hydroxyzine Bluefish |
| Norway | Hydroxyzine Bluefish |
| Poland | Hydroxyzinum Adamed |
| UK | Hydroxyzine hydrochloride 10mg Film-coated tablets |
| France | HYDROXYZINE BLUEFISH 10 mg, compressed pill |