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: PL 46788/0023.


Ropivacaine Altan 2 mg/ml solution for injection

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ropivacaine Altan 2 mg/ml solution for injection

Ropivacaine hydrochloride

Read all of this leaflet carefully before you start using 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, pharmacist or nurse.
  • 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Ropivacaine Altan is and what it is used for
2. What you need to know before you use Ropivacaine Altan
3. How to use Ropivacaine Altan
4. Possible side effects
5. How to store Ropivacaine Altan
6. Contents of the pack and other information

1. WHAT ROPIVACAINE ALTAN IS AND WHAT IT IS USED FOR

Ropivacaine Altan contains ropivacaine hydrochloride which belongs to a group of medicines called local anaesthetics of the amide type.

Ropivacaíne Altan is used in adults and children of all ages for acute pain management. It numbs (anaesthetises) parts of the body e.g. after surgery.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE ROPIVACAINE ALTAN

You must not be given Ropivacaine Altan

  • If you are allergic to ropivacaine, other local anaesthetics of the amide type or any of the other ingredients of this medicine (listed in section 6).
  • In case of intravenous regional anaesthesia (injection into a blood vessel to numb a specific area of your body), or obstretric paracervical anaesthesia (injection into the neck of the womb to relieve pain during childbirth).
  • If you have been told that you have decreased volume of blood (hypovolaemia) as you can develop a decrease in the blood pressure.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Ropivacaine Altan.

Special care should be taken to avoid any injection of Ropivacaine Altan directly in a blood vessel in order to prevent from any immediate toxic effect. Injection should not be performed on an inflamed area.

Inform your doctor:

  • If you suffer from a bad medical condition in general due to age or other factors.
  • If you have heart problems (partial or complete block of the cardiac conduction)
  • If you have an advanced liver problem
  • If you have severe kidney problems

Tell your doctor if you have any of these problems because your doctor may need to adjust the dose of Ropivacaine Altan.

Inform your doctor:

  • If you suffer from acute porphyria (problems with the red pigments of the blood which sometimes results on neurologic symptoms).

Tell your doctor if you or anyone in your family has porphyria because your doctor may need to use a different anaesthetic.

Children and adolescents

Use of Ropivacaine Altan in premature infants has not been studied.

Take special care with Ropivacaine Altan:

  • in newborn children as they are more susceptible to Ropivacaine Altan.
  • in children < 12 years as some injections in order to numb parts of the body are not established in younger children.

Other medicines and Ropivacaine Altan

Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Ropivacaine Altan can affect the way some medicines work and some medicines can have an effect on Ropivacaine Altan.

In particular, tell your doctor if you are taking any of the following medicines:

  • Other local anaesthetics
  • Strong pain killers, such as morphine or codeine.
  • Drugs used to treat an uneven heart beat (arrhythmia), such as lidocaine and mexiletine.

Your doctor needs to know about these medicines to be able to work out the correct dose of Ropivacaine Altan for you.

Take into account that these instructions may be also for medicines which have been taken/used before or may be taken/used after.

Also tell your doctor if you are taking any of the following medicines:

  • Medicines for depression (such as fluvoxamine)
  • Antibiotics to treat infections caused by bacteria (such as enoxacin).

This is because your body takes longer to get rid of Ropivacaine Altan if you are taking these medicines. If you are taking either of these medicines, prolonged use of Ropivacaine Altan should be avoided.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before this medicine is given to you.

Ropivacaine Altan should not be used during pregnancy and breast-feeding unless at the discretion of the doctor it is clearly necessary.

It is not known if ropivacaine hydrochloride passes into breast milk.

Driving and using machines

Ropivacaine Altan may make you feel sleepy and affect the speed of your reactions. After you have been given Ropivacaine Altan, you should not drive or use tools or machines until the next day.

Ropivacaine Altan contains sodium

This medicine contains 3.34 mg sodium (main component of cooking/table salt) in each ml. This is equivalent to 0.17% of the recommended maximum daily dietary intake of sodium for an adult.

3. HOW TO USE ROPIVACAINE ALTAN

Method of administration

Ropivacaine Altan will be given to you by a doctor or, occasionally, by a nurse under medical supervision.

Doses

The dose that your doctor gives you will depend on the type of pain relief that you need. It will also depend on your body size, age, and physical condition.

Ropivacaine Altan will be given to you as an injection. The part of the body where it will be used will depend on why you are being given Ropivacaine Altan. Your doctor will give you Ropivacaine Altan in one of the following places:

  • The part of the body that needs to be numbed.
  • Near to the part of the body that needs to be numbed.
  • In an area away from the part of the body that needs to be numbed. This is the case if you are given an epidural injection or infusion (into the area around the spinal cord).

When Ropivacaine Altan is used in one of these ways, it stops the nerves from being able to pass pain messages to the brain. It will stop you feeling pain, heat or cold in where it is used however you may still have other feelings like pressure or touch.

Your doctor will know the correct way to give you this medicine.

If you have been given more Ropivacaine Altan than you should

Serious side effects from getting too much Ropivacaine Altan need special treatment and the doctor treating you is trained to deal with these situations. The first signs of being given too much Ropivacaine Altan are usually as follows:

  • Feeling dizzy or light-headed.
  • Numbness of the lips and around the mouth.
  • Numbness of the tongue.
  • Hearing problems.
  • Problems with your sight (vision).

To reduce the risk of serious side effects, your doctor will stop giving you Ropivacaine Altan as soon as these signs appear. This means that if any of these happen to you, or you think you have received too much Ropivacaine Altan, tell your doctor immediately.

More serious side effects from being given too much Ropivacaine Altan include problems with your speech, twitching of your muscles, tremors, trembling, fits (seizures), and loss of consciousness.

If you experience any of these symptoms or you think you may have received too much Ropivacaine Altan tell to your doctor or healthcare personnel immediately.

In case of acute toxicity, healthcare personnel will take the appropriate corrective measures immediately.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Important side effects to look out for:

Sudden life-threatening allergic reactions (such as anaphylaxis) are rare, affecting 1 to 10 users in 10,000.

Possible symptoms include sudden onset of rash, itching or lumpy rash (hives); swelling of the face, lips, tongue or other parts of the body; and shortness of breath, wheezing or difficulty breathing. If you think that Ropivacaine Altan is causing an allergic reaction, tell your doctor immediately.

Allergic reactions (in most severe cases, anaphylactic shock) have been associated with local anaesthetics.

Other possible side effects:

Very common

(affects more than 1 patients in 10)

  • Low blood pressurea (hypotension). This might make you feel dizzy or light-headed.
  • Feeling sick (nausea).

Common:

(affects 1 to 10 patients in 100)

  • Headache.
  • Tingling or abnormal sensation of the sensitivity (parestesia).
  • Feeling dizzy.
  • Slow or fast heart beat (bradycardia, tachycardia).
  • High blood pressure (hypertension).
  • Vomitingb.
  • Difficulty in passing urine (urinary retention).
  • High temperature (fever) or shivering (chills).
  • Rigidity.
  • Back pain.

Uncommon

(affects 1 to 10 patients in 1,000)

  • Anxiety.
  • Some symptoms can happen if the injection was given into a blood vessel by mistake, or if you have been given too much Ropivacaine Altan (see also section 3 ‘If you have been given more Ropivacaine Altan than you should’ above). These include fits (seizures, crisis), feeling dizzy or light-headed, numbness of the lips and around the mouth, numbness of the tongue, hearing problems, problems with your sight (vision), problems with your speech (dysarthria), stiff muscles and trembling).
  • Decrease in the sense of touch (hypoestesia).
  • Fainting (syncope).
  • Difficulty breathing (dyspnoea).
  • Low body temperature (hypothermia).

Rare

(affects 1 to 10 patients in 10,000)

  • Heart attack (cardic arrest).
  • Uneven heart beat (arrhythmias).

a Low blood pressure is less frequent in children (at least 1 patients in 100).

b Vomiting are more frequent in children (at least 1 patients in 10).

Other possible side effects include:

  • Numbness, due to nerve irritation caused by the needle or the injection. This does not usually last for long.
  • Involuntary muscle movements (dyskinesia).

Possible side effects observed with other local anaesthetics that may also been produced by Ropivacaine Altan include:

  • Damaged nerves. Rarely this may cause permanent problems.
  • If too much Ropivacaine Altan is given into the spinal fluid, the whole body may become numbed (anaesthetised).

Children

In children, the side effects are the same as in adults except for low blood pressure which happens less often in children (affecting less than 1 in 100 children) and being sick which happens more often in children (affecting more than 1 in 10 children).

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 Yellow Card Scheme, Website: 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 ROPIVACAINE ALTAN

Keep this medicine out of the sight and reach of children.

Do not freeze.

Do not use this medicine after the expiry date which is stated on the carton or the label after CAD. The expiry date refers to the last day of that month.

From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Do not throw away any medicines via wastewater or household waste. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Ropivacaine Altan contains

  • The active substance is ropivacaine hydrochloride. Each 10 ml ampoule contains 20 mg ropivacaine hydrochloride.
  • The other ingredients (excipients) are: sodium chloride, sodium hydroxide (to adjust pH), hydrochloric acid (to adjust pH) and water for injections.

What Ropivacaine Altan looks like and contents of the pack

Ropivacaine Altan is a clear, colourless solution for injection.

Each container contains 5 ampoules of 10 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Altan Pharma Ltd
The Lennox Building
50 South Richmond street
Dublin 2
D02FK02
Ireland

Manufacturer

Altan Pharmaceuticals S.A.
Polígono Industrial de Bernedo s/n
01118 Bernedo (Álava)
España

Or

Altan Pharmaceuticals S.A.
Avda. de la Constitución
198-199, Polígono Industrial Monte Boyal
Casarrubios del Monte
45950 Toledo

This leaflet was last revised in December 2018