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TENSIUM TABLETS, DIAZEPAM 10 MG - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - TENSIUM TABLETS, DIAZEPAM 10 MG

DIAZEPAM TABLETS

PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE.

KEEP THIS LEAFLET UNTIL YOU HAVE FINISHED ALL THE PRESCRIBED COURSE OF DIAZEPAM.

IF YOU HAVE ANY QUESTIONS CONCERNING YOUR MEDICINE ASK YOUR DOCTOR OR PHARMACIST FOR MORE INFORMATION.

What is in Diazepam tablets?

The active ingredient of this medicine is Diazepam BP.

Diazepam tablets come in three strengths:

Diazepam 2 mg tablets which contains 2mg Diazepam, together with the ingredients Lactose, Maize starch, Pregelatinised maize starch and Magnesium stearate (E572).

Diazepam 5 mg tablets which contains 5mg Diazepam, together with the ingredients Lactose, Maize starch, Pregelatinised maize starch, Magnesium stearate (E572) and Quinoline yellow (E104).

Diazepam 10 mg tablets which contains 10mg Diazepam, together with the ingredients Lactose, Maize starch, Magnesium stearate (E572) and Indigo carmine DFC blue 2 (E132).

Diazepam 2mg is a round, flat, white tablet with bevelled edges and embossed 2mg/DDSA.

Diazepam 5mg is a round, flat, pale yellow tablet with bevelled edges and embossed 5mg/DDSA.

Diazepam 10mg is a round flat, pale blue tablet with bevelled edges and a scoreline, and is embossed Tensium.

All three strengths are available in containers of 50, 100, 500 and 1,000 tablets.

Diazepam belongs to a group of medicines, the benzodiazepines that slow down the nervous system and are known as Central Nervous System (CNS) depressants.

The name and address of the Product Licence holder of Diazepam is:

Chelonia Healthcare Limited, Boumpoulinas 11, 3rd Floor, Nicosia, P. C. 1060, Cyprus

The name and address of the manufacturer of Diazepam is: Meridian Healthcare (UK) Ltd., 208–214 York Road, Battersea, London SW11 3SD

Why have you been prescribed Diazepam?

In adults Diazepam is used for the short-term relief (2 – 4 weeks only) of nervousness or tension which is disabling or which can cause unacceptable distress either on its own or together with trouble in falling asleep or in sleeping, known as insomnia.

Diazepam is also used to help relax muscles or relieve muscle spasm which may occur with conditions such as fibrositis and arthritis, bursitis and cervical spondylosis, and to treat certain types of seizure such as those of epilepsy and tetanus.

Diazepam is used for the treatment of the symptoms of alcohol withdrawal.

Diazepam is also used for premedication for dental and surgical procedures.

In children Diazepam is used for the treatment of sleepwalking (somnambulism) and nightmares (night terrors). It is also used in certain conditions to help relax muscles and relieve muscle spasm.

Diazepam is also used for premedication for dental and surgical procedures.

BEFORE TAKING THIS MEDICINE

Before taking this medicine tell your doctor if you have ever had any unusual or allergic reactions to diazepam or other benzodiazepines. Also tell your doctor or pharmacist if you are allergic to any other substances, such as foods, preservatives or dyes.

The presence of other medical problems

The presence of other medical problems may affect the use of this medicine. Make sure, therefore, to tell your doctor if you have any other medical problems, especially:

  • Any condition that affects your breathing, such as asthma, emphysema.
  • Any liver or kidney problems for which you have or are receiving treatment.
  • Raised eyeball pressure (Glaucoma)
  • Depression

The effect of taking Diazepam with other medicines

This medicine will add to the effects of alcohol and other medicines that slow down the Central Nervous System (CNS), possibly causing drowsiness. Some examples of CNS depressants are antihistamines (medicines for hayfever and other allergies); sedatives; tranquillisers, sleeping medicines; pain relieving medicines; barbiturates; medicines for seizures; muscle relaxants; anaesthetics including some dental anaesthetics.

Make sure you doctor is informed of any medication you are taking, whether it has been prescribed or bought without a prescription. It is particularly important that your doctor is aware of any medicines you are taking which have been mentioned in the paragraph above.

If you go to a doctor, dentist or hospital for any reason, tell them you are taking Diazepam.

PRECAUTIONS WHILE USING THIS MEDICINE

Driving and using machines


When Diazepam has been combined during treatment with CNS depressants, sedative effects of these are likely to be intensified, and may last for a few days after you have stopped taking this medicine.

Diazepam can affect your ability to drive and use machines as it may make you feel sleepy and dizzy.

Do not drive or operate dangerous machinery while taking this medicine until you know how it affects you.

  • It is an offence to drive if this medicine affects your ability to drive.
  • However, you would not be committing an offence if:

  • – Diazepam has been prescribed to treat a medical or dental problem and;

  • – you have taken it according to the instructions given by the prescriber or in the information provided with the medicine and;

  • – it was not affecting your ability to drive safely Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Sources: Original (products.mhra.gov.uk)

Frequently Asked Questions

What is TENSIUM tablets used for?

TENSIUM tablets, which contain Diazepam 10 mg, are used to treat anxiety, muscle spasms, and seizures. They may also be prescribed for certain sleep disorders.

How does Diazepam work in TENSIUM tablets?

Diazepam works by enhancing the effects of a natural chemical in the body called GABA. This results in a calming effect on the brain, helping to reduce anxiety and muscle spasms.

Can I take TENSIUM if I have a history of substance abuse?

It is important to inform your doctor about any history of substance abuse before taking TENSIUM, as Diazepam can be habit-forming.

How long does it take for TENSIUM tablets to start working?

TENSIUM tablets typically start to work within 30 minutes to an hour after ingestion, but this can vary based on individual factors.

Is it safe to take TENSIUM during pregnancy?

You should consult your doctor if you are pregnant or planning to become pregnant. Diazepam can affect fetal development.

Can I drink alcohol while taking TENSIUM tablets?

No, you should avoid alcohol while taking TENSIUM, as it can increase the sedative effects of Diazepam and lead to dangerous side effects.

What should I do if I miss a dose of TENSIUM?

If you miss a dose of TENSIUM, take it as soon as you remember. If it’s almost time for your next dose, skip the missed dose and continue with your regular schedule.

Can children take TENSIUM tablets?

TENSIUM is not typically recommended for children under 18 unless prescribed by a healthcare provider due to safety concerns.

What are some common side effects of TENSIUM tablets?

Common side effects may include drowsiness, fatigue, dizziness, and confusion. Consult your doctor if these persist or worsen.

Can I stop taking TENSIUM suddenly?

No, you should not stop taking TENSIUM suddenly without consulting your doctor, as this can cause withdrawal symptoms.

Are there any food interactions with TENSIUM tablets?

There are no specific food interactions with TENSIUM; however, it’s best to avoid large amounts of caffeine.

Is it safe to drive after taking TENSIUM tablets?

You may feel drowsy or dizzy after taking TENSIUM; it's advisable to avoid driving or operating heavy machinery until you know how it affects you.

What should I do if I overdose on TENSIUM?

If you suspect an overdose of TENSIUM, seek immediate medical attention or call emergency services right away.

How should I store TENSIUM tablets?

Store TENSIUM tablets at room temperature away from moisture and heat. Keep them out of reach of children.

Can I take other medications with TENSIUM?

Always consult your healthcare provider before combining TENSIUM with other medications to avoid potential interactions.

What happens if I take more than the prescribed dose of TENSIUM?

Taking more than the prescribed dose can lead to serious side effects including respiratory depression. Contact your healthcare provider immediately.

How long can I safely take TENSIUM tablets?

Your doctor will determine the appropriate duration based on your condition; long-term use should be monitored due to dependency risks.

Can I use TENSIUM for stress relief before a big event?

Some people may use it for acute anxiety; however, consult your doctor for appropriate advice tailored to your situation.

What is the best way to take my dosage of TENSIUM effectively?

Take your dosage exactly as directed by your healthcare provider; typically with a full glass of water either with or without food.

Are there alternative treatments for anxiety besides using TENSIUM?

Yes, alternatives include therapy options such as cognitive-behavioral therapy (CBT), lifestyle changes or other medications. Consult your healthcare professional for personalized recommendations.