Package leaflet: Information for the user
[product name] 3 mg hard capsules [product name] 6 mg hard capsules
bromazepam
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet 1. What [product name] is and what it is used for 2. What you need to know before you take [product name] 3. How to take [product name] 4. Possible side effects 5. How to store [product name] 6. Contents of the pack and other information
1. What [product name] is and what it is used for
The active substance of [product name], bromazepam, belongs to a group of medicines called benzodiazepines.
[product name] is used to treat: - anxiety syndrome - adjuvant treatment for symptoms of anxiety associated with psychiatric disorders, such as mood swings or schizophrenia.
Benzodiazepines are used only when the disturbance is severe, incapacitating or the individual is subject to extreme anxiety.
2. What you need to know before you take [product name]
Do not take [product name] - if you are allergic to bromazepam or any of the other ingredients of this medicine (listed in section 6) or to other benzodiazepine medicines - if you have severe breathing problems or lung disease - if you have muscular problems - if you have severe liver problems - if you have a condition called ‘sleep apnoea syndrome’ (where your breathing stops when you are asleep).
Warnings and precautions Talk to your doctor or pharmacist before taking [product name] - if you have any liver, kidney or lung problems
- if you have muscle weakness - if you suffer other illnesses eg. depression - if you have drug or alcohol addition problems.
Children Do not give [product name] to children.
Other medicines and [product name] Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines: - medicines to treat mental health problems (such as diazepam) - medicines to help you sleep (such as zolpidem) - medicines for allergies, which make you sleepy (such as diphenhydramine) - medicines to treat epilepsy (such as clozapine) - cimetidine (used to treat stomach problems and heartburn) - propranolol (used to treat high blood pressure, tremors, and chest pain) - fluvoxamine (used to treat obsessive-compulsive disorder and anxiety) - strong painkillers (such as morphine) - strong medicines for treating infections including HIV (for example, protease inhibitors).
Concomitant use of [product name] and opioids (strong pain killers, medicines for substitution therapy and some cough medicines) increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
However if your doctor does prescribe [product name] together with opioids the dose and duration of concomitant treatment should be limited by your doctor.
Please tell your doctor about all opioid medicines you are taking, and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
[product name] with food and drink Avoid alcoholic beverages during treatment. The effect of alcohol can enhance sedation and this may cause serious problems with your breathing and heartbeat. If you need additional information about this point, contact your doctor.
Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide if you should take [product name].
Bromazepam pass into breast milk, thus your doctor will decide whether you should take [product name] or not during breastfeeding.
Driving and using machines [product name] can affect the ability to drive and use machines, as it can lead to drowsiness, decreased attention or decreased ability to react. These side effects are more likely to occur at the beginning of treatment or when the dose is increased. Do not drive or use machinery if you experience any of these effects.
Use in elderly people
Elderly people may be affected by [product name] more than younger patients. Your doctor may prescribe a lower dose and check your response to treatment. Please follow carefully the instructions given by your doctor.
[product name] contains lactose, Ponceau 4R (E 124) and Sunset yellow (E 110, 3 mg capsules only) Lactose: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Ponceau 4R (E 124) and Sunset yellow (E 110, 3 mg capsules only): May cause allergic reactions.
3. How to take [product name]
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Depending on the nature of your illness, your age and weight, your doctor will prescribe the appropriate dose for you. Your doctor will give you the lowest possible dose that works for you.
[product name] capsules should be swallowed whole, not chewed with some water or a non-alcoholic drink.
The usual dose of [product name] is from 1.5 mg to 3 mg three times a day (4.5 mg – 9 mg daily). In most of cases, only a short-course of treatment with [product name] is needed. You will normally take this medicine for no more than 12 weeks.
In patients who have been hospitalized, a higher dose may be needed, but always have to be prescribed by a doctor.
In elderly patients and patients with liver or kidney problems the doctor will prescribe a lower dose.
Use in children [product name] is not recommended for use in children less than 12 years of age.
If you take more [product name] than you should If you or someone else has taken an overdose of [product name], call immediately to a doctor or the nearest hospital. The manifestation of a benzodiazepine overdose, in mild cases, usually consists of drowsiness, lack of co-ordination, slurred speech or jerky eye movements. The ingestion of high doses, especially in combination with other centrally acting substances, can cause ataxia, areflexia, apnea, hypotension, respiratory depression, and occasional coma.
If you forget to take [product name] Do not take a double dose to make up for a forgotten dose, on the contrary, you should continue the normal dosage.
If you stop taking [product name] Restlessness, anxiety, muscle pain, diarrhoea and headache may occur, especially if you have been taking it for a long time. In general, it is not recommended to abruptly discontinue the medication but to gradually reduce the dose according to the instructions given by your doctor.
Never change the prescribed dose yourself. If you think the effect is too strong or too weak, consult your doctor.
Remember that [product name] is not indicated for long treatments, after a few weeks of treatment your doctor will lower the dose until you stop taking it.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking [product name] and see a doctor straight way if you notice any of the following serious side effects - you may need urgent medical treatment: - Severe allergic reaction. The signs may include: - Sudden swelling of the throat, face, lips and mouth. This may make it difficult to breathe or swallow. - Sudden swelling of the hands, feet and ankles - Skin rash or itching. - Heart problems including heart failure (may be seen as breathlessness, swelling of the ankles, cough, tiredness and a racing heart) and cardiac arrest. - Breathing problems (respiratory depression). Early signs include suddenly noisy, difficult and uneven breathing. Your skin may become blue. - Being restless, aggressive, angry, irritable or agitated. - Nightmares and seeing or possibly hearing things that are not really there (hallucinations). - Mental problems such as delusions (believing in things that are not real) or losing contact with reality. - A change in your behaviour that is out of character.
When you start taking [product name] you may notice the following effects: - feeling drowsy, sleepy and tired - feeling little or no emotion - being less alert - feeling confused - headache - feeling dizzy - feeling sick or being sick (nausea and vomiting) - weak muscles - poor co-ordination, including ataxia feeling unsteady when you walk - problems with your eye-sight (double vision). These effects usually go away after some time. If you are worried talk to your doctor or pharmacist.
The following effects may occur at any time during your treatment - difficulty remembering new things, this may be at the same time as changed or strange behaviour - depression - constipation - skin rashes, itchy skin and reddening of the skin - a higher or lower interest in sex - difficulty passing water (urinating).
Injury: - Patients taking benzodiazepine medicines are at risk of falling and breaking bones. This risk is increased in the elderly and those taking other sedatives (including alcohol).
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store [product name]
Keep this medicine out of the reach and sight of children.
Store below 30ºC.
Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What [product name] contains - The active substance is bromazepam. Each capsule contains 3 mg or 6 mg of bromazepam. - The other ingredients are: Capsule content: Lactose monohydrate, maize starch, colloidal anhydrous silica and magnesium stearate. Capsule shell: Gelatin, titanium dioxide (E 171), ponceau 4R (E 124), Sunset Yellow FCF (E 110) (3 mg capsules only) and black iron oxide (E 172) (6 mg capsules only).
What [product name] looks like and contents of the pack 3 mg capsules: Orange/red hard capsules, with size no. 4, containing white or yellowish powder. 6 mg capsules: Grey/pink hard capsules, with size no. 4, containing white or yellowish powder.
Pack sizes 20, 30 or 50 capsules in blister pack. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Orion Corporation Orionintie 1 FI-02200 Espoo Finland
Manufacturers
Orion Corporation Orion Pharma Orionintie 1 FI-02200 Espoo Finland
Orion Corporation Orion Pharma Joensuunkatu 7
FI-24100 Salo Finland
Laboratorios Normon S.A. Ronda de Valdecarrizo, 6 28760 Tres Cantos, Madrid Spain
This leaflet was last revised in 19.9.2018