What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: 44490/0004.


Slow Sodium

PACKAGE LEAFLET: INFORMATION FOR THE USER

SLOW SODIUM TABLETS

Read all of this leaflet carefully before you start taking this medicine.

  • 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.
    Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Slow Sodium tablets are and what they are used for
2. Before you take Slow Sodium tablets
3. How to take Slow Sodium tablets
4. Possible side effects
5. How to store Slow Sodium tablets
6. Further information

1. WHAT SLOW SODIUM TABLETS ARE AND WHAT THEY ARE USED FOR

Slow Sodium tablets contain the active ingredient sodium chloride (salt) in a special slow-release form. Slow Sodium tablets are used for the treatment and prevention of sodium chloride deficiency.

2. BEFORE YOU TAKE SLOW SODIUM TABLETS

Do not take Slow Sodium tablets if you:

  • are allergic (hypersensitive) to any of the ingredients of Slow Sodium tablets (see list of ingredients in Section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.
  • have fluid retention
  • have heart disease
  • have heart failure
  • have aldosteronism (a condition where too much aldosterone [a hormone] is produced)
  • are having treatment to produce salt and water loss, usually if you have fluid retention or heart failure or have high blood pressure.

Take special care with Slow Sodium tablets if you:

  • have a condition of the intestines, where narrowing may occur e.g. Crohn's disease, diverticulitis or stricture (band) formation (usually after major abdominal surgery).
  • think you may have a problem drinking enough water.

Please tell your doctor if any of the above applies to you.

Taking other medicines

You should tell your doctor if you are taking or have taken any medicines, including those obtained without a prescription. In particular, Slow Sodium may affect drugs (e.g. furosemide, bumetanide, metolazone) used to treat high blood pressure particularly if you also have a kidney disorder.

It may still be all right for you to be given Slow Sodium tablets and your doctor will be able to decide what is suitable for you.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant or breast-feeding and your doctor will decide if it is ok for you to be given Slow Sodium tablets.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Slow Sodium tablets should have no effect on your ability to drive or use machines.

3. HOW TO TAKE SLOW SODIUM TABLETS

Dosage

Always take Slow Sodium tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose is:

Adults:

To prevent sodium chloride defficiency:

4-8 tablets per day.

For cases of severe salt loss:

up to 20 tablets per day may be needed.

To control muscle cramps during haemodialysis:

(treatment with a kidney machine) 10-16 tablets.

Children:

The dose is adjusted to the child's needs.

The tablets should be swallowed whole with water (about 70 ml per tablet) and not chewed.

If you take more Slow Sodium tablets than you should

Tell your doctor straight away or go to the nearest casualty department immediately, taking the tablet container with you.

If you forget to take Slow Sodium tablets

If you miss a dose, take one as soon as you can. If you have missed several doses, tell your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

No side effects have been reported at the recommended doses.

If you notice any side effects please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE SLOW SODIUM TABLETS

Keep out of the sight and reach of children. Do not use the drug after the date indicated on the carton. Do not store above 30°C. Protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer needed. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Slow Sodium tablets contain

The active substance is sodium chloride.

Each tablet contains the equivalent of 600mg of sodium chloride.

The other ingredients are: cetostearyl alcohol, gelatin, magnesium stearate, hypromellose phthalate (E464), hydroxypropyl cellulose (E463), talc and titanium dioxide (171).

What Slow Sodium tablets looks like and contents of the pack

The tablets are round, white and polished.

They are available in containers of 100 tablets.

Marketing Authorisation Holder

ALTURIX Ltd
287 Upper Fourth Street
Milton Keynes
MK9 1EH

Manufacturer

Kymos Pharma Services, S.L.
Ronda de Can Fatjó, 7B
(Parque Tecnológico del Vallès)
Cerdanyola del Vallès 08290
(Barcelona) España

This medicinal product is authorised in the Member States of the EEA under the following names:

Slow Sodium

This leaflet was last revised in

July 2020

Product Licence Number

PL 44490/0004