5 mg, 10 mg, 15 mg tablets
Oxazepam
What Sobril is and what it is used for
Sobril contains the active substance oxazepam and belongs to a group of medicines called benzodiazepines. These work by enhancing the effect of a dampening substance ( GABA ) in the brain. As a result, Sobril has an anti-anxiety, muscle-relaxing, and calming effect.
Sobril is used for worry, anxiety, restlessness, and difficulty sleeping in connection with nervous disorders. Sobril can be used together with antidepressant medication for depression with elements of anxiety.
Sobril can also be used to treat withdrawal symptoms associated with alcohol abuse, such as confusion, anxiety, tension, and excitement.
The oxazepam contained in Sobril may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Sobril
Do not take Sobril:
- if you are allergic to oxazepam or any of the other ingredients of this medicine (listed in section 6).
- if you have sleep apnea (breathing pauses during sleep).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Sobril if you:
- are older. In the elderly, confusion may occur after excessively high doses.
- have reduced liver function
- have reduced kidney function
- have a disease that causes muscle weakness ( myasthenia gravis )
- have breathing difficulties ( respiratory insufficiency )
- has reduced general condition
- have an addiction (eg drug or alcohol abuse)
- have had difficulty sleeping for a long time
- are taking other medicines for mental disorders (e.g. sedatives, medicines for sleep difficulties, medicines for depression or psychosis ).
There is a risk that you will become dependent on this medicine, especially with long-term treatment. Follow your doctor’s dosage recommendations. Talk to your doctor if you are unsure.
Abruptly stopping treatment may cause withdrawal symptoms, see section 3 “If you stop taking Sobril” for further information.
Children and young people
Efficacy and safety in children under 18 years of age have not been established. Sobril should not be given to children unless the doctor considers it necessary. The treatment time should be as short as possible.
Other medicines and Sobril
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines. This applies in particular to:
- opioid medicines (such as strong pain relievers, medicines to treat opioid addiction, and some cough medicines). Simultaneous use increases the risk of drowsiness, breathing difficulties ( respiratory depression ), and coma, and can be life-threatening and should therefore only be considered by the doctor when other treatment options are not possible. Contact a doctor if you experience symptoms such as drowsiness or difficulty breathing ( respiratory depression ).
- contraceptives ( birth control pills )
Sabriel with food, drink, and alcohol
You should avoid drinking alcohol during treatment with this medicine, as Sobril and alcohol can enhance each other’s 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.
Pregnancy
There is a risk that the fetus will be affected. Therefore, always consult your doctor before using Sobril during pregnancy.
Breastfeeding
Passes into breast milk but probably does not affect children who are breastfed. Advise though
always consult your doctor before using Sobril during breastfeeding.
Driving ability and use of machinery
During treatment with Sobril, the ability to react may be reduced and you may experience side effects such as e.g. dizziness, drowsiness, hallucinations, and aggressiveness which may affect your ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Sobril contains wheat starch
This medicine contains only very low levels of gluten (from wheat starch) and is considered “gluten-free”. It is very unlikely to cause problems if you have gluten intolerance ( celiac disease ).
A 5 mg tablet contains no more than 0.7 micrograms of gluten.
A 10 mg tablet contains no more than 1.3 micrograms of gluten.
A 15 mg tablet contains no more than 1.5 micrograms of gluten.
If you are allergic to wheat (a disease other than gluten intolerance) you should not use this medicine.
Sobril contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. is almost “sodium-free”.
How to take Sobril
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The dose is determined by the doctor who adjusts it individually for you. The tablet should be swallowed.
If you have taken too much Sobril
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice. Take this leaflet or some tablets with you so the doctor knows what you have taken.
Symptoms of overdose may be:
Difficulty coordinating muscle movements, dizziness, difficulty speaking, muscle weakness, sleepiness or unconsciousness, agitation (restlessness), aggression, hallucinations (seeing and hearing things that are not there), pupils may become larger or smaller, difficulty breathing, drop in blood pressure, faster heartbeat, low body temperature, nausea or vomiting.
If you forget to take Sobril
If you forget to take a dose, take it as soon as you remember unless it is soon time to take the next dose. Do not take a double dose to make up for a missed dose. Talk to your doctor if you are unsure.
If you stop taking Sobril
Do not stop treatment without first talking to your doctor.
After prolonged use, the treatment should not be stopped suddenly, but the dose must instead be reduced gradually. This reduces the risk of withdrawal symptoms. Abruptly stopping treatment may cause withdrawal symptoms such as restless sleep for a few nights; a tingling or burning sensation in the skin, psychological symptoms, and abnormal sensations that last for one or more weeks.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects are dose-dependent and older people are more sensitive.
Common side effects (may affect up to 1 in 10 users) :
- Drowsiness (occurs in about 10-15% of all patients, but usually subsides after a few days of treatment)
Uncommon side effects (may affect up to 1 in 100 users):
- headache
- dizziness
- difficulty coordinating muscle movements
- muscle weakness
- memory gaps at high dose er
Rare side effects (may affect up to 1 in 1,000 users):
- allergic skin reactions
- breathing difficulties ( respiratory depression )
- insomnia
- nightmares
- excitement
- aggressiveness
- seeing and hearing things that are not there (hallucinations)
How Sobril should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the packaging after EXP.
The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is oxazepam. One tablet contains 5 mg, 10 mg, and 15 mg of oxazepam respectively.
- Other excipients are microcrystalline cellulose, calcium hydrogen phosphate, wheat starch (see section 2 “Sobril contains wheat starch”), sodium starch glycolate, magnesium stearate, anhydrous colloidal silicon dioxide, povidone, sodium lauryl sulfate (see section 2 “Sobril contains sodium”).
Appearance and package sizes of the medicine
5 mg: White, round, biconvex tablet, marked SM within brackets on one side and scored on the other side.
10 mg: White, round, biconvex tablet, marked SB within brackets on one side and scored on the other side.
15 mg: White, round, biconvex tablet, marked SL within brackets on one side.
Package sizes:
Blisters: 25 and 100 tablets
Plastic container: 250 tablets (for dose dispensing only).
Single-dose blister: 49×1 tablets
Single-dose blister: 7×1 tablets (10 mg only)
Not all pack sizes may be marketed.
Pfizer AB
191 90 Sollentuna
Phone: 08-550 520 00
Email: eumedinfo@pfizer.com