Solifenacin Dr.Reddy’s

Solifenacin Dr.Reddy’s

Active ingredient(s): solifenacin succinate

---

Consumer Medicine Information (CMI)

This leaflet provides important information about using Solifenacin Dr.Reddy’s. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Solifenacin Dr.Reddy’s.

Where to find information in this leaflet:

1. Why am I using Solifenacin Dr.Reddy’s?
2. What should I know before I use Solifenacin Dr.Reddy’s?
3. What if I am taking other medicines?
4. How do I use Solifenacin Dr.Reddy’s?
5. What should I know while using Solifenacin Dr.Reddy’s?
6. Are there any side effects?
7. Product details

1. Why am I taking Solifenacin Dr.Reddy’s?

Solifenacin Dr.Reddy’s contains the active ingredient solifenacin succinate. Solifenacin Dr.Reddy’s belongs to a group of medicines called anticholinergic medicines. It works by acting on specialised cells to reduce the activity of your bladder and help you control your bladder.

Solifenacin Dr.Reddy’s is used to treat the symptoms of overactive bladder.

These symptoms include needing to rush to the toilet to urinate without warning, needing to urinate frequently, or wetting yourself because you did not get to the toilet in time.

Ask your doctor if you have any questions about why Solifenacin Dr.Reddy’s has been prescribed for you.

Your doctor may have prescribed it for another purpose.

There is no evidence that Solifenacin Dr.Reddy’s is addictive.

2. What should I know before I take Solifenacin Dr.Reddy’s?

Warnings

Do not take Solifenacin Dr.Reddy’s if:

• you are allergic to solifenacin, or any of the ingredients listed at the end of this leaflet.
  Symptoms of allergic reaction may include skin rash, itching or hives, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, wheezing or shortness of breath.

Do not take Solifenacin Dr.Reddy’s if you:

• suffer from urinary retention (inability to urinate or empty your bladder completely)
• are undergoing haemodialysis
• have severe kidney disease or moderate liver disease and are also taking medicines that can decrease the removal of Solifenacin Dr.Reddy’s from the body (see 3. What if I am taking other medicines)
• have severe liver disease
• have uncontrolled glaucoma (high pressure in the eyes, with gradual loss of eyesight)
• have myasthenia gravis, a disease of the muscles causing drooping eyelids, double vision, difficulty in speaking or swallowing and sometimes muscle weakness in the arms or legs
• have a blocked gastro-intestinal tract or other gastro-intestinal disorders such as ulcerative colitis or toxic megacolon.

Check with your doctor if you:

Have or have had, any medical conditions, especially the following

• low potassium levels or a family history of heart rhythm problems. Solifenacin Dr.Reddy’s may have an effect on the electro-cardiogram (ECG-a heart tracing) and may add to the effect of other medicines on the ECG. You should advise your doctor of any other medicines you are currently taking, particularly those affecting the heart rhythm. Your doctor may wish to perform an ECG if you have any risks of having an abnormal heart rhythm.
• blockage to your bladder that cause difficulty urinating
• obstruction of the digestive system (constipation)
• glaucoma (high pressure in the eyes, with gradual loss of eye sight)
• hiatus hernia or gastric reflux or are currently being treated with some medicines (such as bisphosphonates) which may make your reflux worse
• autonomic neuropathy, a nerve problem which sometimes occurs with diabetes and can lead to diarrhoea, impotence or low blood pressure
• severe kidney disease
• moderate liver disease

Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

You must tell your doctor if you are pregnant or planning to become pregnant.

Solifenacin Dr.Reddy’s may affect your developing baby if you take it during pregnancy. Your doctor will decide if you should take it.

Tell your doctor if you are breastfeeding.

Do not take Solifenacin Dr.Reddy’s if you are breastfeeding.

Children

Do not give Solifenacin Dr.Reddy’s to children.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Solifenacin Dr.Reddy’s and affect how it works.

Some medicines can slow down the removal of Solifenacin Dr.Reddy’s from the body. If you are taking any of the following, 5 mg a day is the maximum recommended dosage:

• Some antifungal medicines such as ketoconazole, itraconazole
• ritonavir and nelfinavir, medicines to treat HIV infection.

If you are taking any of the above medicines and you also have severe kidney disease or moderate liver disease, you should not take Solifenacin Dr.Reddy’s.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Solifenacin Dr.Reddy’s.

4. How do I use Solifenacin Dr.Reddy’s?

Follow all directions given to you by your doctor carefully.

These directions may differ from the information contained in this leaflet.

How much to take

• The usual dose is 5 to 10 mg of Solifenacin Dr.Reddy’s once a day. Your doctor will decide the most suitable dose for you.
• Talk to your doctor or pharmacist if you feel that the effect of Solifenacin Dr.Reddy’s is too strong or too weak.

When to take Solifenacin Dr.Reddy’s

• Take Solifenacin Dr.Reddy’s at about the same time each day.

How to take Solifenacin Dr.Reddy’s

• Swallow the tablets with a glass of water.
• Solifenacin Dr.Reddy’s can be taken with or without food.
• Do not crush or chew the tablets.

If you crush or chew Solifenacin Dr.Reddy’s tablets, they may not work as well.

How long to take Solifenacin Dr.Reddy’s

To properly control your condition, Solifenacin Dr.Reddy’s must be taken every day.

Keep taking Solifenacin Dr.Reddy’s for as long as your doctor recommends.

If you forget to take Solifenacin Dr.Reddy’s

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take the missed dose as soon as you remember, and then go back to taking your tablets as you would normally.

Do not take a double dose to make up for the dose you missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you take too much Solifenacin Dr.Reddy’s

If you think that you have taken too much Solifenacin Dr.Reddy’s, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Solifenacin Dr.Reddy’s?

Things you should do

Before starting any medicine, tell your doctor or pharmacist that you are taking Solifenacin Dr.Reddy’s. Visit your doctor regularly so they can check on your progress.

Tell all the doctors, dentists and pharmacists who are treating you that you are taking Solifenacin Dr.Reddy’s.

Things you should not do

• Do not stop taking Solifenacin Dr.Reddy’s, or lower the dose, without checking with your doctor
• Do not use Solifenacin Dr.Reddy’s to treat any other conditions unless your doctor tells you to.
• Do not give Solifenacin Dr.Reddy’s to anyone else, even if they have the same condition as you.

Things to be careful of

Be careful driving or operating machinery until you know how Solifenacin Dr.Reddy’s affects you.

Solifenacin Dr.Reddy’s can sometimes cause blurred vision and less frequently drowsiness and fatigue.

Do not drive or operate machinery if you suffer from any of these side effects.

Looking after your medicine

Store it in a cool dry place where the temperature stays below 25°C, away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

Do not use Solifenacin Dr.Reddy’s if the packaging shows signs of tampering.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects

What to do

dry mouth nausea, vomiting constipation indigestion heartburn (dyspepsia) stomach discomfort urinary tract infection, bladder pain difficulty passing urine, inability to empty the bladder urgent need to urinate blurred vision inability to empty the bladder dry eyes tiredness muscle weakness accumulation of fluids (swelling) in the lower limbs (oedema) dizziness sore/dry throat cough headache sleepiness hallucination confusion depression fast heartbeat palpitations skin reactions such as rash, itching or hives.

Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects	What to do
allergic reactions including swelling of the face, lips, throat or tongue, difficulty breathing. chest pain or tightness swelling of the feet or legs changes in electrical activity of the heart (ECG), irregular heartbeat (Torsade de Points)	Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Some of these side effects (for example, changes in electrical activity of the heart or liver function) can only be found when your doctor does tests from time to time to check your progress.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What Solifenacin Dr.Reddy’s contains

Active ingredient (main ingredient)	solifenacin succinate
Other ingredients (inactive ingredients)	Lactose monohydrate Hypromellose Magnesium stearate Titanium dioxide Purified talc Triacetin Iron oxide yellow (5 mg tablets only) Iron oxide red (10 mg tablets only) Solifenacin Dr.Reddy’s contains sugars as lactose
Potential allergens	N/A

Do not take this medicine if you are allergic to any of these ingredients.

What Solifenacin Dr.Reddy’s looks like

Solifenacin Dr.Reddy’s 5 mg film-coated tablets are light yellow coloured, round-shaped biconvex film-coated tablets debossed with ‘S5’ on one side and plain on the other side. (AUST R 370705).

Solifenacin Dr.Reddy’s 10 mg film coated tablets are light pink coloured, round-shaped biconvex film-coated tablets debossed with ‘S10’ on one side and plain on the other side. (AUST R. 370706)

Each blister contains 10 or 30 tablets.

Who distributes Solifenacin Dr.Reddy’s

Dr.Reddy’s Laboratories (Australia) Pty Ltd
Head Office
Suite 3.03, Level 3, 390 St Kila Road
Melbourne, Victoria 3004
T: +6183941888

This leaflet was prepared in September 2021.